Dolocam Plus

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Dolocam Plus uses

Dolocam Plus consists of Meloxicam, Methocarbamol.

Meloxicam:


1 INDICATIONS AND USAGE

Dolocam Plus Tablets are non-steroidal anti-inflammatory drug indicated for:

  • Osteoarthritis (OA) (1.1)
  • Rheumatoid Arthritis (RA) (1.2)

1.1 Osteoarthritis (OA)

Dolocam Plus (Meloxicam) tablets are indicated for relief of the signs and symptoms of osteoarthritis [see CLINICAL STUDIES (14.1)].

1.2 Rheumatoid Arthritis

Dolocam Plus (Meloxicam) tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see CLINICAL STUDIES (14.1)].

2 DOSAGE AND ADMINISTRATION

Use the lowest effective dose for the shortest duration consistent with individual treatment goals for the individual patient.

  • OA and RA (2.3):
  • Starting dose: 7.5 mg once daily
  • Dose may be increased to 15 mg once daily

2.1 General Instructions

Carefully consider the potential benefits and risks of Dolocam Plus (Meloxicam) tablets and other treatment options before deciding to use Dolocam Plus (Meloxicam) tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS (5.4)].

After observing the response to initial therapy with Dolocam Plus (Meloxicam) tablets, adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of Dolocam Plus (Meloxicam) tablets are 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see WARNINGS AND PRECAUTIONS (5.6), USE IN SPECIFIC POPULATIONS (8.7) AND CLINICAL PHARMACOLOGY (12.3)].

Dolocam Plus (Meloxicam) may be taken without regard to timing of meals.

2.2 Osteoarthritis

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of Dolocam Plus tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

2.3 Rheumatoid Arthritis

For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of Dolocam Plus (Meloxicam) tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

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3 DOSAGE FORMS AND STRENGTHS

  • Tablets: 7.5 mg, 15 mg (3)

Tablets:

  • 7.5 mg: yellow, round-shaped, flat beveled edge, uncoated tablets debossed with ‘ZC’ and ‘25’ on one side and plain on other side
  • 15 mg: yellow, round-shaped, flat beveled edge, uncoated tablet debossed with ‘ZC’ and ‘26’ on one side and plain on other side

4 CONTRAINDICATIONS

  • Known hypersensitivity to Dolocam Plus (Meloxicam) (4.1)
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4.1)
  • Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery (4.2)

4.1 Allergic Reactions

Dolocam Plus (Meloxicam) Tablets are contraindicated in patients with known hypersensitivity (e.g. anaphylactoid reactions and serious skin reactions) to Dolocam Plus (Meloxicam). Dolocam Plus (Meloxicam) tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS (5.7, 5.13)].

4.2 Coronary Surgery

Dolocam Plus (Meloxicam) tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS (5.1)].

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5 WARNINGS AND PRECAUTIONS

  • Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk. (5.1)
  • Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly. (5.2)
  • Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen. (5.3)
  • New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment. (5.4)
  • Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure. (5.5)
  • Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists. The use of Dolocam Plus (Meloxicam) in patients with severe renal impairment is not recommended (5.6)
  • Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue Dolocam Plus (Meloxicam) at first appearance of rash or skin reactions. (5.8)

5.1 Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years’ duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS (4.2)].

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events [see WARNINGS AND PRECAUTIONS (5.2)].

5.2 Gastrointestinal Effects - Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including Dolocam Plus (Meloxicam), can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs, occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

Prescribe NSAIDs, including Dolocam Plus (Meloxicam), with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during Dolocam Plus (Meloxicam) therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of Dolocam Plus (Meloxicam) until a serious GI adverse event is ruled out. For high-risk patients, consider alternate therapies that do not involve NSAIDs.

5.3 Hepatic Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Dolocam Plus. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported [see ADVERSE REACTIONS (6.1)].

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Dolocam Plus (Meloxicam). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue Dolocam Plus (Meloxicam) [see USE IN SPECIFIC POPULATIONS (8.6) AND CLINICAL PHARMACOLOGY (12.3)].

5.4 Hypertension

NSAIDs, including Dolocam Plus (Meloxicam), can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including Dolocam Plus (Meloxicam), should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Patients taking ACE inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

5.5 Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Use Dolocam Plus with caution in patients with fluid retention, hypertension, or heart failure.

5.6 Renal Effects

Long-term administration of NSAIDs, including Dolocam Plus (Meloxicam), can result in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, ACE-inhibitors, and angiotensin II receptor antagonists, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

A pharmacokinetic study in patients with mild and moderate renal impairment revealed that no dosage adjustments in these patient populations are required. Patients with severe renal impairment have not been studied. The use of Dolocam Plus (Meloxicam) in patients with severe renal impairment with CrCl less than 20 mL/min is not recommended. A study performed in patients on hemodialysis revealed that although overall Cmax was diminished in this population, the proportion of free drug not bound to plasma was increased. Therefore it is recommended that Dolocam Plus (Meloxicam) dosage in this population not exceed 7.5 mg per day. Closely monitor the renal function of patients with impaired renal function who are taking Dolocam Plus (Meloxicam) [see DOSAGE AND ADMINISTRATION (2.1), USE IN SPECIFIC POPULATIONS (8.7) AND CLINICAL PHARMACOLOGY (12.3)].

Use caution when initiating treatment with Dolocam Plus (Meloxicam) in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with Dolocam Plus (Meloxicam). Caution is also recommended in patients with pre-existing kidney disease.

The extent to which metabolites may accumulate in patients with renal impairment has not been studied with Dolocam Plus (Meloxicam). Because some Dolocam Plus (Meloxicam) metabolites are excreted by the kidney, monitor patients with significant renal impairment closely.

5.7 Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions have occurred in patients without known prior exposure to Dolocam Plus. Dolocam Plus (Meloxicam) should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs [see CONTRAINDICATIONS (4.1) AND WARNINGS AND PRECAUTIONS (5.12)]. Seek emergency help in cases where an anaphylactoid reaction occurs.

5.8 Adverse Skin Reactions

NSAIDs, including Dolocam Plus (Meloxicam), can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations and discontinue use of the drug at the first appearance of skin rash or any other sign of hypersensitivity.

5.9 Pregnancy

Starting at 30 weeks gestation, avoid the use of Dolocam Plus, because it may cause premature closure of the ductus arteriosus [see USE IN SPECIFIC POPULATIONS (8.1) AND PATIENT COUNSELING INFORMATION (17.8)].

5.10 Corticosteroid Treatment

Dolocam Plus (Meloxicam) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Slowly taper patients on prolonged corticosteroid therapy if a decision is made to discontinue corticosteroids.

5.11 Masking of Inflammation and Fever

The pharmacological activity of Dolocam Plus in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

5.12 Hematological Effects

Anemia may occur in patients receiving NSAIDs, including Dolocam Plus (Meloxicam). This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Dolocam Plus (Meloxicam), should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Carefully monitor patients treated with Dolocam Plus (Meloxicam) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants.

5.13 Use in Patients with Pre-existing Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Dolocam Plus should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with pre-existing asthma.

5.14 Monitoring

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Dolocam Plus (Meloxicam) should be discontinued.

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6 ADVERSE REACTIONS

  • Most common adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular thrombotic events [ see BOXED WARNINGS AND WARNING AND PRECAUTIONS (5.1)]
  • Gastrointestinal effects [ see BOXED WARNING AND WARNINGS AND PRECAUTIONS (5.2)]
  • Hepatic effects
  • Hypertension
  • Congestive heart failure and edema
  • Renal effects
  • Anaphylactoid reaction
  • Adverse skin reaction

6.1 Clinical Trials Experience

Adults

Osteoarthritis and Rheumatoid Arthritis

The Dolocam Plus (Meloxicam) Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Dolocam Plus (Meloxicam) 7.5 mg/day, 3,505 OA patients and 1351 RA patients treated with Dolocam Plus (Meloxicam) 15 mg/day. Dolocam Plus (Meloxicam) at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Dolocam Plus (Meloxicam) trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Dolocam Plus (Meloxicam) with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Dolocam Plus (Meloxicam) with placebo.

Table 1a depicts adverse events that occurred in ≥2% of the Dolocam Plus (Meloxicam) treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥2% of the Dolocam Plus (Meloxicam) treatment groups in two 12-week placebo- controlled rheumatoid arthritis trials.


Placebo

Dolocam Plus (Meloxicam)

7 . 5 mg daily

Dolocam Plus (Meloxicam)

15 mg daily

Diclofenac 100 mg daily


1WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined

2WHO preferred terms rash, rash erythematous and rash maculo-papular combined

No . of Patients

157

154

156

153

Gastrointestinal

17.2

20.1

17.3

28.1

Abdominal Pain

2.5

1.9

2.6

1.3

Diarrhea

3.8

7.8

3.2

9.2

Dyspepsia

4.5

4.5

4.5

6.5

Flatulence

4.5

3.2

3.2

3.9

Nausea

3.2

3.9

3.8

7.2

Body as a Whole

Accident Household


1.9


4.5


3.2


2.6

Edema1

2.5

1.9

4.5

3.3

Fall

0.6

2.6

0.0

1.3

Influenza-Like Symptoms

5.1

4.5

5.8

2.6

Central and Peripheral

Nervous System






Dizziness


3.2


2.6


3.8


2.0

Headache

10.2

7.8

8.3

5.9

Respiratory






Pharyngitis


1.3


0.6


3.2


1.3

Upper Respiratory Tract

Infection


1.9


3.2


1.9


3.3

Skin






Rash2


2.5


2.6


0.6


2.0


Placebo

Dolocam Plus (Meloxicam)

7 . 5 mg

daily

Dolocam Plus (Meloxicam)

15 mg

daily


1MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)

2MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

No . of Patients

469

481

477

Gastrointestinal disorders

14.1

18.9

16.8

Abdominal pain NOS2

0.6

2.9

2.3

Dyspeptic signs and symptoms1

3.8

5.8

4.0

Nausea2

2.6

3.3

3.8

General disorders and administration site conditions




Influenza like illness2

2.1

2.9

2.3

Infection and infestations




Upper respiratory tract infections-pathogen class unspecified1

4.1

7.0

6.5

Musculoskeletal and connective tissue disorders




Joint related signs and symptoms 1

1.9

1.5

2.3

Nervous system disorders




Headaches NOS2

6.4

6.4

5.5

Skin and subcutaneous tissue disorders




Rash NOS2

1.7

1.0

2.1


The adverse events that occurred with Dolocam Plus (Meloxicam) in ≥2% of patients treated short-term (4-6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2


4 - 6 Weeks Controlled Trials


6 Month Controlled Trials



Dolocam Plus (Meloxicam)

7 . 5 mg daily

Dolocam Plus (Meloxicam)

15 mg daily

Dolocam Plus (Meloxicam)

7 . 5 mg daily

Dolocam Plus (Meloxicam)

15 mg daily

No . of Patients

8955

256

169

306

Gastrointestinal

11.8

18.0

26.6

24.2

Abdominal Pain

2.7

2.3

4.7

2.9

Constipation

0.8

1.2

1.8

2.6

Diarrhea

1.9

2.7

5.9

2.6

Dyspepsia

3.8

7.4

8.9

9.5

Flatulence

0.5

0.4

3.0

2.6

Nausea

2.4

4.7

4.7

7.2

Vomiting

0.6

0.8

1.8

2.6

Body as a Whole





Accident Household

0.0

0.0

0.6

2.9

EdemaWHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined

0.6

2.0

2.4

1.6

Pain

0.9

2.0

3.6

5.2

Central and Peripheral Nervous System

Dizziness


1.1


1.6


2.4


2.6

Headache

2.4

2.7

3.6

2.6

Hematologic

Anemia


0.1


0.0


4.1


2.9

Musculoskeletal

Arthralgia


0.5


0.0


5.3


1.3

Back Pain

0.5

0.4

3.0

0.7

Psychiatric

Insomnia


0.4


0.0


3.6


1.6

Respiratory

Coughing


0.2


0.8


2.4


1.0

Upper Respiratory tract Infection

0.2

0.0

8.3

7.5

Skin

Pruritus


0.4


1.2


2.4


0.0

RashWHO preferred terms rash, rash erythematous, and rash maculo-papular combined

0.3

1.2

3.0

1.3

Urinary

Micturition Frequency


0.1


0.4


2.4


1.3

Urinary Tract Infection

0.3

0.4

4.7

6.9


Higher doses of Dolocam Plus (Meloxicam) (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of Dolocam Plus (Meloxicam) should not exceed 15 mg.

The following is a list of adverse drug reactions occurring in <2% of patients receiving Dolocam Plus (Meloxicam) in clinical trials involving approximately 16,200 patients.

Body as a Whole


allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase

Cardiovascular


angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis

Central and Peripheral Nervous System

convulsions, paresthesia, tremor, vertigo

Gastrointestinal



colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative

Heart Rate and Rhythm

arrhythmia, palpitation, tachycardia

Hematologic

leukopenia, purpura, thrombocytopenia

Liver and Biliary System


ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis

Metabolic and Nutritional

dehydration

Psychiatric


abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence

Respiratory

asthma, bronchospasm, dyspnea

Skin and Appendages


alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria

Special Senses

abnormal vision, conjunctivitis, taste perversion, tinnitus

Urinary System


albuminuria, BUN increased, creatinine increased, hematuria, renal failure

6.2 Post Marketing Experience

The following adverse reactions have been identified during post approval use of Dolocam Plus (Meloxicam). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome, and toxic epidermal necrolysis.

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7 DRUG INTERACTIONS

  • Concomitant use of Dolocam Plus and warfarin may result in increased risk of bleeding complications (7.7)
  • Concomitant use of Dolocam Plus (Meloxicam) and aspirin is not generally recommended because of the potential of increased adverse effect including increased GI bleeding (7.2)
  • Concomitant use with Dolocam Plus (Meloxicam) increases lithium plasma levels (7.4)
  • Concomitant use with NSAIDs may reduce the antihypertensive effect of ACE-inhibitors (7.1)

See also Clinical Pharmacology (12.3).

7.1 ACE-inhibitors

NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking Dolocam Plus (Meloxicam) concomitantly with ACE-inhibitors.

7.2 Aspirin

When Dolocam Plus is administered with aspirin (1000 mg three times daily) to healthy volunteers, an increase the AUC (10%) and Cmax (24%) of Dolocam Plus (Meloxicam) was noted. The clinical significance of this interaction is not known; however, as with other NSAIDs concomitant administration of Dolocam Plus (Meloxicam) and aspirin is not generally recommended because of the potential for increased adverse effects.

Concomitant administration of low-dose aspirin with Dolocam Plus (Meloxicam) may result in an increased rate of GI ulceration or other complications, compared to use of Dolocam Plus (Meloxicam) alone. Dolocam Plus (Meloxicam) is not a substitute for aspirin for cardiovascular prophylaxis.

7.3 Diuretics

Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and Dolocam Plus (Meloxicam) have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of Dolocam Plus (Meloxicam). Nevertheless, during concomitant therapy with Dolocam Plus (Meloxicam), patients should be observed closely for signs of renal failure [see WARNINGS AND PRECAUTIONS (5.6)], as well as to ensure diuretic efficacy.

7.4 Lithium

In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with Dolocam Plus 15 mg every day as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by Dolocam Plus (Meloxicam). Closely monitor patients on lithium treatment for signs of lithium toxicity when Dolocam Plus (Meloxicam) is introduced, adjusted, or withdrawn.

7.5 Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Therefore, NSAIDs may reduce the elimination of methotrexate, thereby enhancing the toxicity of methotrexate. Use caution when Dolocam Plus (Meloxicam) is administered concomitantly with methotrexate [see CLINICAL PHARMACOLOGY (12.3)].

7.6 Cyclosporine

Dolocam Plus, like other NSAIDs, may affect renal prostaglandins, thereby altering the renal toxicity of certain drugs. Therefore, concomitant therapy with Dolocam Plus (Meloxicam) may increase cyclosporine's nephrotoxicity. Use caution when Dolocam Plus (Meloxicam) is administered concomitantly with cyclosporine.

7.7 Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Monitor anticoagulant activity, particularly in the first few days after initiating or changing Dolocam Plus (Meloxicam) therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding than with the use of either drug alone. Use caution when administering Dolocam Plus (Meloxicam) with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [see CLINICAL PHARMACOLOGY (12.3)].

8 USE IN SPECIFIC POPULATIONS

  • Based on animal data, may cause fetal harm. Starting at 30 weeks gestation, Dolocam Plus should be avoided as premature closure of the ductus arteriosus in the fetus may occur. (5.9, 8.1)
  • Nursing Mothers: Use with caution, as Dolocam Plus (Meloxicam) may be excreted in human milk (8.3)

8.1 Pregnancy

Pregnancy Category C; Category D starting 30 weeks gestation.

There are no adequate and well-controlled studies in pregnant women. Dolocam Plus (Meloxicam) crosses the placental barrier. Prior to 30 weeks gestation, use Dolocam Plus (Meloxicam) during pregnancy only if the potential benefit justifies the potential risk to the fetus. Starting at 30 weeks gestation, avoid Dolocam Plus (Meloxicam) and other NSAIDs, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [see WARNINGS AND PRECAUTIONS (5.9) AND PATIENT COUNSELING INFORMATION (17.8)]

Teratogenic Effects

Dolocam Plus (Meloxicam) was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [MRHD] based on body surface area [BSA] comparison). Administration of Dolocam Plus (Meloxicam) to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion).

Nonteratogenic Effects

In rats and rabbits, embryolethality occurred at oral Dolocam Plus (Meloxicam) doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.

8.2 Labor and Delivery

The effects of Dolocam Plus on labor and delivery of pregnant women are unknown. Oral administration of Dolocam Plus (Meloxicam) to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at Dolocam Plus (Meloxicam) doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison).

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk; however, Dolocam Plus (Meloxicam) was excreted in the milk of lactating rats at concentrations higher than those in plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dolocam Plus (Meloxicam) a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Use of this drug for a pediatric indication is protected by marketing exclusivity.

8.5 Geriatric Use

As with any NSAID, caution should be exercised in treating the elderly.

Of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in OA studies and 1113 in RA studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6 Hepatic Impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since Dolocam Plus (Meloxicam) is significantly metabolized in the liver, the use of Dolocam Plus (Meloxicam) in these patients should be done with caution [see WARNINGS AND PRECAUTIONS (5.3) AND CLINICAL PHARMACOLOGY (12.3)].

8.7 Renal Impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been studied. The use of Dolocam Plus (Meloxicam) in subjects with severe renal impairment is not recommended. Following a single dose of Dolocam Plus (Meloxicam), the free Cmax plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). Therefore it is recommended that Dolocam Plus (Meloxicam) dosage in this population not exceed 7.5 mg per day Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Dolocam Plus (Meloxicam) is not dialyzable [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.6) AND CLINICAL PHARMACOLOGY (12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

There is limited experience with Dolocam Plus (Meloxicam) overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of Dolocam Plus (Meloxicam).

Symptoms following acute NSAID overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed with symptomatic and supportive care following an NSAID overdose. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of Dolocam Plus (Meloxicam) by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

11 DESCRIPTION

Dolocam Plus (Meloxicam), an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each yellow Dolocam Plus (Meloxicam) tablet contains 7.5 mg or 15 mg Dolocam Plus (Meloxicam) for oral administration. Dolocam Plus (Meloxicam) is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula.

Dolocam Plus (Meloxicam) is a pale yellow powder, practically insoluble in water, slightly soluble in acetone, soluble in dimethylformamide, very slightly soluble in ethanol (96 %) and in methanol. Dolocam Plus (Meloxicam) has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Dolocam Plus (Meloxicam) has pKa values of 1.1 and 4.2.

Each Dolocam Plus (Meloxicam) tablet intended for oral administration contains 7.5 mg or 15 mg of Dolocam Plus (Meloxicam). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of Dolocam Plus, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition which is involved in the initial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.

12.2 Pharmacodynamics

Dolocam Plus (Meloxicam) exhibits anti-inflammatory, analgesic, and antipyretic activities.

12.3 Pharmacokinetics

Absorption

The absolute bioavailability of Dolocam Plus capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg. After multiple oral doses the pharmacokinetics of Dolocam Plus (Meloxicam) capsules were dose-proportional over the range of 7.5 mg to 15 mg. Mean Cmax was achieved within four to five hours after a 7.5 mg Dolocam Plus (Meloxicam) tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady-state concentrations were reached by Day 5. A second Dolocam Plus (Meloxicam) concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Pharmacokinetic

Parameters

(% CV )


Steady State


Single Dose



Healthy male adults

( Fed ) not under high fat conditions

Elderly males ( Fed )

Elderly females

( Fed )

Renal failure

( Fasted )

Hepatic insufficiency

( Fasted )


7 . 5 mgDolocam Plus (Meloxicam) tablets tablets

15 mg capsules

15 mg capsules

15 mg capsules

15 mg capsules

N

18

5

8

12

12

Cm a x [µg/mL] 1.05 (20)

2.3 (59)

3.2 (24)

0.59 (36)

0.84 (29)

tm a x [h]

4.9 (8)

5 (12)

6 (27)

4 (65)

10 (87)

t½ [h]

20.1 (29)

21 (34)

24 (34)

18 (46)

16 (29)

CL/f {mL/min}

8.8 (29)

9.9 (76)

5.1 (22)

19 (43)

11 (44)

VzfVz/f =Dose/(AUC-Ke l) [L]

14.7(32)

15 (42)

10 (30)

26 (44)

14 (29)

Food and Antacid Effects

Administration of Dolocam Plus (Meloxicam) capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., Cmax) being increased by approximately 22% while the extent of absorption (AUC) was unchanged. The time to maximum concentration (Tmax) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the Cmax values for Dolocam Plus (Meloxicam) suspension were affected following a similar high fat meal, while mean Tmax values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids. Based on these results, Dolocam Plus (Meloxicam) can be administered without regard to timing of meals or concomitant administration of antacids.

Distribution

The mean volume of distribution of Dolocam Plus (Meloxicam) is approximately 10 L. Dolocam Plus (Meloxicam) is ~99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range. The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to ~99% in patients with renal disease. Dolocam Plus (Meloxicam) penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged Dolocam Plus (Meloxicam).

Dolocam Plus (Meloxicam) concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.

Metabolism

Dolocam Plus (Meloxicam) is extensively metabolized in the liver. Dolocam Plus (Meloxicam) metabolites include 5'-carboxy Dolocam Plus (Meloxicam) (60% of dose), from P-450 mediated metabolism formed by oxidation of an intermediate metabolite 5'-hydroxymethyl Dolocam Plus (Meloxicam) which is also excreted to a lesser extent (9% of dose). In vitro studies indicate that CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in this metabolic pathway with a minor contribution of the CYP3A4 isozyme. Patients’ peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively. All the four metabolites are not known to have any in vivo pharmacological activity.

Excretion

Dolocam Plus excretion is predominantly in the form of metabolites, and occurs to equal extents in the urine and feces. Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%). The extent of the urinary excretion was confirmed for unlabeled multiple 7.5 mg doses: 0.5%, 6%, and 13% of the dose were found in urine in the form of Dolocam Plus (Meloxicam), and the 5'-hydroxymethyl and 5'-carboxy metabolites, respectively. There is significant biliary and/or enteral secretion of the drug. This was demonstrated when oral administration of cholestyramine following a single IV dose of Dolocam Plus (Meloxicam) decreased the AUC of Dolocam Plus (Meloxicam) by 50%.

The mean elimination half-life (t1/2) ranges from 15 hours to 20 hours. The elimination half-life is constant across dose levels indicating linear metabolism within the therapeutic dose range. Plasma clearance ranges from 7 to 9 mL/min.

Special Populations

Geriatric

Elderly males (≥ 65 years of age) exhibited Dolocam Plus (Meloxicam) plasma concentrations and steady-state pharmacokinetics similar to young males. Elderly females ( ≥ 65 years of age) had a 47% higher AUCss and 32% higher Cmax,ss as compared to younger females (≤ 55 years of age) after body weight normalization. Despite the increased total concentrations in the elderly females, the adverse event profile was comparable for both elderly patient populations. A smaller free fraction was found in elderly female patients in comparison to elderly male patients.

Gender

Young females exhibited slightly lower plasma concentrations relative to young males. After single doses of 7.5 mg Dolocam Plus (Meloxicam), the mean elimination half-life was 19.5 hours for the female group as compared to 23.4 hours for the male group. At steady state, the data were similar (17.9 hours vs 21.4 hours). This pharmacokinetic difference due to gender is likely to be of little clinical importance. There was linearity of pharmacokinetics and no appreciable difference in the Cmax or Tmax across genders.

Hepatic Impairment

Following a single 15 mg dose of Dolocam Plus (Meloxicam) there was no marked difference in plasma concentrations in patients with mild (Child-Pugh Class I) or moderate (Child-Pugh Class II) hepatic impairment compared to healthy volunteers. Protein binding of Dolocam Plus (Meloxicam) was not affected by hepatic impairment. No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment (Child-Pugh Class III) have not been adequately studied [see WARNINGS AND PRECAUTIONS (5.3) AND USE IN SPECIFIC POPULATIONS (8.6)].

Renal Impairment

Dolocam Plus (Meloxicam) pharmacokinetics have been investigated in subjects with mild and moderate renal impairment. Total drug plasma concentrations of Dolocam Plus (Meloxicam) decreased and total clearance of Dolocam Plus (Meloxicam) increased with the degree of renal impairment while free AUC values were similar in all groups. The higher Dolocam Plus (Meloxicam) clearance in subjects with renal impairment may be due to increased fraction of unbound Dolocam Plus (Meloxicam) which is available for hepatic metabolism and subsequent excretion. No dosage adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been adequately studied. The use of Dolocam Plus (Meloxicam) in subjects with severe renal impairment is not recommended [see WARNINGS AND PRECAUTIONS (5.6) AND USE IN SPECIFIC POPULATIONS (8.7)].

Hemodialysis

Following a single dose of Dolocam Plus (Meloxicam), the free Cmax plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Dolocam Plus (Meloxicam) is not dialyzable [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.6) AND USE IN SPECIFIC POPULATIONS (8.7)].

Drug Interactions

Aspirin

When Dolocam Plus (Meloxicam) is administered with aspirin (1000 mg three times daily) to healthy volunteers, it tended to increase the AUC (10%) and Cmax (24%) of Dolocam Plus (Meloxicam). The clinical significance of this interaction is not known [see DRUG INTERACTIONS (7.2)].

Cholestyramine

Pretreatment for four days with cholestyramine significantly increased the clearance of Dolocam Plus (Meloxicam) by 50%. This resulted in a decrease in t1/2, from 19.2 hours to 12.5 hours, and a 35% reduction in AUC. This suggests the existence of a recirculation pathway for Dolocam Plus (Meloxicam) in the gastrointestinal tract. The clinical relevance of this interaction has not been established.

Cimetidine

Concomitant administration of 200 mg cimetidine four times daily did not alter the single-dose pharmacokinetics of 30 mg Dolocam Plus (Meloxicam).

Digoxin

Dolocam Plus (Meloxicam) 15 mg once daily for 7 days did not alter the plasma concentration profile of digoxin after β-acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and Dolocam Plus (Meloxicam).

Lithium

In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with Dolocam Plus (Meloxicam) 15 mg QD every day as compared to subjects receiving lithium alone [see DRUG INTERACTIONS (7.4)].

Methotrexate

A study in 13 rheumatoid arthritis (RA) patients evaluated the effects of multiple doses of Dolocam Plus (Meloxicam) on the pharmacokinetics of methotrexate taken once weekly. Dolocam Plus (Meloxicam) did not have a significant effect on the pharmacokinetics of single doses of methotrexate. In vitro, methotrexate did not displace Dolocam Plus (Meloxicam) from its human serum binding sites [see DRUG INTERACTIONS (7.5)].

Warfarin

The effect of Dolocam Plus (Meloxicam) on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of warfarin that produced an INR (International Normalized Ratio) between 1.2 and 1.8. In these subjects, Dolocam Plus (Meloxicam) did not alter warfarin pharmacokinetics and the average anticoagulant effect of warfarin as determined by prothrombin time. However, one subject showed an increase in INR from 1.5 to 2.1. Caution should be used when administering Dolocam Plus (Meloxicam) with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [see DRUG INTERACTIONS (7.7)].

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

There was no increase in tumor incidence in long-term carcinogenicity studies in rats and mice (99 weeks) administered Dolocam Plus (Meloxicam) at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-fold, respectively, the maximum recommended human daily dose based on body surface area comparison).

Mutagenesis

Dolocam Plus (Meloxicam) was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility

Dolocam Plus (Meloxicam) did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-fold greater, respectively, than the maximum recommended human daily dose based on body surface area comparison).

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Osteoarthritis and Rheumatoid Arthritis

The use of Dolocam Plus (Meloxicam) for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. Dolocam Plus (Meloxicam) (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness). Patients on Dolocam Plus (Meloxicam) 7.5 mg daily and Dolocam Plus (Meloxicam) 15 mg daily showed significant improvement in each of these endpoints compared with placebo.

The use of Dolocam Plus (Meloxicam) for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks’ to 6 months’ duration. In these trials, the efficacy of Dolocam Plus (Meloxicam), in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.

The use of Dolocam Plus (Meloxicam) for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. Dolocam Plus (Meloxicam) (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving Dolocam Plus (Meloxicam) 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

Dolocam Plus (Meloxicam) Tablets, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with ‘ZC’ and ‘25’ on one side and plain on other side and are supplied as follows:

Bottle of 15 – 68788-9898-1

Bottle of 20 - 68788-9898-2

Bottle of 30 - 68788-9898-3

Bottle of 60 - 68788-9898-6

Bottle of 100 - 68788-9898-0

Dolocam Plus (Meloxicam) Tablets, 15 mg are yellow, round-shaped, flat beveled edge, uncoated tablet debossed with ‘ZC’ and ‘26’ on one side and plain on other side and are supplied as follows:

Bottle of 15 - 68788-9897-1

Bottle of 20 - 68788-9897-2

Bottle of 30 - 68788-9897-3

Bottle of 60 - 68788-9897-6

Bottle of 100 - 68788-9897-0

Storage

Store at 20° to 25° C (68° to 77° F). Keep Dolocam Plus (Meloxicam) tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

17.1 Medication Guide

Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using Dolocam Plus tablets.

17.2 Cardiovascular Effects

NSAIDs including Dolocam Plus (Meloxicam), may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see WARNINGS AND PRECAUTIONS (5.1)].

17.3 Gastrointestinal Effects

NSAIDs including Dolocam Plus, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [see WARNINGS AND PRECAUTIONS (5.2)].

17.4 Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [see WARNINGS AND PRECAUTIONS (5.3)].

17.5 Adverse Skin Reactions

NSAIDs, including Dolocam Plus, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [see WARNINGS AND PRECAUTIONS (5.8)].

17.6 Weight Gain and Edema

Advise patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [see WARNINGS AND PRECAUTIONS (5.5)].

17.7 Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction. Instruct patients to seek immediate emergency help [see WARNINGS AND PRECAUTIONS (5.7)].

17.8 Effects During Pregnancy

Starting at 30 weeks gestation, Dolocam Plus (Meloxicam) should be avoided as premature closure of the ductus arteriosus in the fetus may occur [see WARNINGS AND PRECAUTIONS (5.9) AND USE IN SPECIFIC POPULATIONS (8.1)].

Please address medical inquiries to, (MedicalAffairsDolocam Plus (Meloxicam)zydususa.com) Tel.: 1-877-993-8779.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 04/11

Revision Date : 29/04/2011

Relabeled By Preferred Pharmaceuticals, Inc

Medication Guide

for

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

.

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and "anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin orany other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions
  • about all of the medicines you take. NSAIDs and some other medicines caninteract with each other and cause serious side effects. Keep a list of yourmedicines to show to your healthcare provider and pharmacist
  • if you are pregnant. NSAID medicines should not be used by pregnant womenlate in their pregnancy
  • if you are breastfeeding. Talk to your doctor

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include :

Other side effects include :

- heart attack

- stomach pain

- stroke

- constipation

- high blood pressure

- diarrhea

- heart failure from body swelling (fluid retention)

- gas

- kidney problems including kidney failure

- heartburn

- bleeding and ulcers in the stomach and

- nausea

- intestine

- vomiting

- low red blood cells (anemia)

- dizziness

- life-threatening skin reactions


- life-threatening allergic reactions


- liver problems including liver failure


- asthma attacks in people who have asthma



Get emergency help right away if you have any of the following symptoms:

- shortness of breath or trouble breathing

- slurred speech

- chest pain

- swelling of the face or throat

- weakness in one part or side of your body



Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

- nausea

- more tired or weaker than usual

- itching

- your skin or eyes look yellow

- stomach pain

- flu-like symptoms

- vomit blood

- there is blood in your bowel movement or it is black and sticky like tar

- unusual weight gain

- skin rash or blisters with fever

- swelling of the arms and legs, hands and feet


These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

Aspirin is an NSAID medicine but it does not increase the chance of a heartattack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without aprescription (over-the-counter). Talk to your healthcare provider before usingover-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name

Product Trademark ( s )

Celecoxib

Celebrex

Diclofenac

Cataflam, Voltaren, Arthrotec (combined with misoprostol)

Diflunisal

Dolobid

Etodolac

Lodine , Lodine XL

Fenoprofen

Nalfon, Nalfon 200

Flurbiprofen

Ansaid

Ibuprofen

Motrin, Tab-Profen, VicoprofenVicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. (combined with hydrocodone), Combunox (combined with oxycodone)

Indomethacin

Indocin, Indocin SR, Indo-Lemmon, Indomethagan

Ketoprofen

Oruvail

Ketorolac

Toradol

Mefenamic Acid

Ponstel

Dolocam Plus (Meloxicam)

Mobic

Nabumetone

Relafen

Naproxen

Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, PREVACID, NapraPAC (copackaged with lansoprazole)

Oxaprozin

Daypro

Piroxicam

Feldene

Sulindac

Clinoril

Tolmetin

Tolectin, Tolectin DS, Tolectin 600


All registered trademarks in this document are the property of their respective owners.

Please address medical inquiries to, (MedicalAffairsDolocam Plus (Meloxicam)zydususa.com) Tel.: 1-877-993-8779.

This Medication Guide has been approved by the US Food and Drug Administration.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 04/11

Revision Date : 29/04/2011

Relabeled By Preferred Pharmaceuticals, Inc

Methocarbamol:



Dolocam Plus (Methocarbamol) TABLETS, USP

Rev. 03/11

Rx Only

DESCRIPTION:

Dolocam Plus (Methocarbamol) Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:


The chemical name for Dolocam Plus (Methocarbamol) is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.

Dolocam Plus (Methocarbamol) is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

Each tablet, for oral administration, contains 500 mg or 750 mg of Dolocam Plus (Methocarbamol), USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.

Dolocam Plus (Methocarbamol) structural formula

CLINICAL

Pharmacology:

The mechanism of action of Dolocam Plus in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics :

In healthy volunteers, the plasma clearance of Dolocam Plus (Methocarbamol) ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Dolocam Plus (Methocarbamol) is metabolized via dealkylation and hydroxylation. Conjugation of Dolocam Plus (Methocarbamol) also is likely. Essentially all Dolocam Plus (Methocarbamol) metabolites are eliminated in the urine. Small amounts of unchanged Dolocam Plus (Methocarbamol) also are excreted in the urine.

Special Populations :

Elderly

The mean elimination half-life of Dolocam Plus (Methocarbamol) in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hours, respectively). The fraction of bound Dolocam Plus (Methocarbamol) was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

Renally Impaired

The clearance of Dolocam Plus (Methocarbamol) in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (±SD) elimination half-life in these two groups was similar: 1.2 (±0.6) versus 1.1 (±0.3) hours, respectively.

Hepatically Impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of Dolocam Plus (Methocarbamol) was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours, respectively. The percent of Dolocam Plus (Methocarbamol) bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

INDICATIONS AND USAGE:

Dolocam Plus (Methocarbamol) Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of Dolocam Plus (Methocarbamol) has not been clearly identified, but may be related to its sedative properties. Dolocam Plus (Methocarbamol) does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS:

Methocarbamol Tablets are contraindicated in patients hypersensitive to Dolocam Plus (Methocarbamol) or to any of the tablet components.

WARNINGS:

Since Dolocam Plus may possess a general CNS depressant effect, patients receiving Dolocam Plus (Methocarbamol) Tablets should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Dolocam Plus (Methocarbamol) Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to Dolocam Plus (Methocarbamol). Therefore, Dolocam Plus (Methocarbamol) Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS : Pregnancy ).

Use in Activities Requiring Mental Alertness :

Dolocam Plus (Methocarbamol) may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that Dolocam Plus (Methocarbamol) therapy does not adversely affect their ability to engage in such activities.

PRECAUTIONS:

Information for Patients:

Patients should be cautioned that Dolocam Plus may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.

Because Dolocam Plus (Methocarbamol) may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Drug Interactions:

See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.

Dolocam Plus (Methocarbamol) may inhibit the effect of pyridostigmine bromide. Therefore, Dolocam Plus (Methocarbamol) should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

Drug /Laboratory Test Interactions:

Dolocam Plus may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

Carcinogenesis, Mutagenesis, Impairment of Fertility :

Long-term studies to evaluate the carcinogenic potential of Dolocam Plus (Methocarbamol) have not been performed. No studies have been conducted to assess the effect of Dolocam Plus (Methocarbamol) on mutagenesis or its potential to impair fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Dolocam Plus. It is also not known whether Dolocam Plus (Methocarbamol) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol Tablets should be given to a pregnant woman only if clearly needed.

Safe use of Dolocam Plus (Methocarbamol) Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congential abnormalities following in utero exposure to Dolocam Plus (Methocarbamol). Therefore, Dolocam Plus (Methocarbamol) Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS ).

Nursing Mothers

Dolocam Plus (Methocarbamol) and/or its metabolites are excreted in the milk of dogs; however, it is not known whether Dolocam Plus (Methocarbamol) or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dolocam Plus (Methocarbamol) Tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Dolocam Plus (Methocarbamol) Tablets in pediatric patients below the age of 16 have not been established.

ADVERSE REACTIONS

Adverse reactions reported coincident with the administration of Dolocam Plus (Methocarbamol) include:

Body as a Whole : Anaphylactic reaction, angioneurotic edema, fever, headache

Car d iovascular System : Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive System : Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and Lymphatic S ystem : Leukopenia

Immune System : Hypersensitivity reactions

Nervous System : Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and Special Senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Limited information is available on the acute toxicity of Dolocam Plus. Overdose of Dolocam Plus (Methocarbamol) is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of Dolocam Plus (Methocarbamol) alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

Treatment:

Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

DOSAGE AND ADMINISTRATION:

500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.

750 mg – Adults: Initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

HOW SUPPLIED:

Dolocam Plus (Methocarbamol) Tablets 500 mg: White, Round Tablets; Debossed “West-ward 290” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Dolocam Plus (Methocarbamol) Tablets 750 mg: White, Capsule Shaped Tablets; Debossed “WEST-WARD 292” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Store at 20-25oC (68-77oF). Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised March 2011

Dolocam Plus pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Dolocam Plus available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Dolocam Plus destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Dolocam Plus Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Dolocam Plus pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."METHOCARBAMOL TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MELOXICAM TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."METHOCARBAMOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dolocam Plus?

Depending on the reaction of the Dolocam Plus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dolocam Plus not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dolocam Plus addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Dolocam Plus, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dolocam Plus consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

One visitor reported side effects

Did you get side effects while taking the Dolocam Plus drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Dolocam Plus medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

Visitor reported price estimates

No survey data has been collected yet

Two visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Dolocam Plus drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Dolocam Plus is mentioned below.
Visitors%
Twice in a day1
50.0%
Once in a day1
50.0%

Eight visitors reported doses

What is the dose of Dolocam Plus drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
101-200mg2
25.0%
11-50mg2
25.0%
1-5mg1
12.5%
201-500mg1
12.5%
501mg-1g1
12.5%
6-10mg1
12.5%

Visitor reported time for results

No survey data has been collected yet

One visitor reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Dolocam Plus drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
After food1
100.0%

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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