Antigrippin-Maximum Lemon

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Antigrippin-Maximum Lemon uses

Antigrippin-Maximum Lemon consists of Acetaminophen, Calcium Gluconate Monohydrate, Loratadine, Rimantadine Hydrochloride, Rutin, Vitamin C (Ascorbic Acid).

Acetaminophen:


Pharmacological action

Antigrippin-Maximum Lemon is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.

Why is Antigrippin-Maximum Lemon (Acetaminophen) prescribed?

Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.

Antigrippin-Maximum Lemon dosage and administration

Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission - up to 4 times / Maximum duration of treatment - 5-7 days.

Maximum dose: single - 1 g, daily - 4 g.

Single dose for oral administration for children aged 6-12 years - 250-500 mg, 1-5 years - 120-250 mg, from 3 months to 1 year - 60-120 mg, up to 3 months - 10 mg / kg. Single dose rectal in children aged 6-12 years - 250-500 mg, 1-5 years - 125-250 mg.

Multiplicity - 4 at intervals of not less than 4 h. The maximum duration of treatment - 3 days.

Maximum dose: 4 single dose per day.

Antigrippin-Maximum Lemon side effects, adverse reactions

Digestive system: rarely - dyspepsia; long-term use at high doses - hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia. Hemopoietic system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis. Allergic reactions: rarely - skin rash, itching, hives.

Contraindications

Chronic active alcoholism, increased sensitivity to Antigrippin-Maximum Lemon, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).

Using during pregnancy and breastfeeding

Antigrippin-Maximum Lemon (Acetaminophen) crosses the placental barrier. So far, no observed adverse effects of Antigrippin-Maximum Lemon (Acetaminophen) on the fetus in humans.

Antigrippin-Maximum Lemon (Acetaminophen) is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.

If necessary, use of Antigrippin-Maximum Lemon (Acetaminophen) during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.

In experimental studies found no embryotoxic, teratogenic and mutagenic action of Antigrippin-Maximum Lemon (Acetaminophen).

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Special Instructions

Antigrippin-Maximum Lemon is used with caution in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.

With prolonged use of Antigrippin-Maximum Lemon (Acetaminophen) is necessary to monitor patterns of peripheral blood and functional state of the liver.

Used for treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).

Antigrippin-Maximum Lemon (Acetaminophen) Drug Interactions

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of Antigrippin-Maximum Lemon (Acetaminophen).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Antigrippin-Maximum Lemon (Acetaminophen).

With the simultaneous use of oral contraceptives accelerated excretion of Antigrippin-Maximum Lemon (Acetaminophen) from the body and may reduce its analgesic action.

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Antigrippin-Maximum Lemon (Acetaminophen).

When Antigrippin-Maximum Lemon (Acetaminophen) applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Antigrippin-Maximum Lemon (Acetaminophen). A case of severe toxic liver injury.

Described cases of toxic effects of Antigrippin-Maximum Lemon (Acetaminophen), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Antigrippin-Maximum Lemon (Acetaminophen), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Antigrippin-Maximum Lemon (Acetaminophen) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Antigrippin-Maximum Lemon (Acetaminophen) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Antigrippin-Maximum Lemon (Acetaminophen) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Antigrippin-Maximum Lemon (Acetaminophen), with rifampicin, sulfinpyrazone - may increase clearance of Antigrippin-Maximum Lemon (Acetaminophen) due to increasing its metabolism in the liver.

At simultaneous application of Antigrippin-Maximum Lemon (Acetaminophen) with ethinylestradiol increases absorption of Antigrippin-Maximum Lemon (Acetaminophen) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

Antigrippin-Maximum Lemon in case of emergency / overdose

At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.

Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms

Calcium Gluconate Monohydrate:


1 INDICATIONS AND USAGE

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

- Starting dose is 2 capsules with each meal. (2)

- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate capsule.

- Capsule: 667 mg Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Antigrippin-Maximum Lemon acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate. (5.1)

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate), including Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate. Avoid the use of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) supplements, including Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) based nonprescription antacids, concurrently with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate.

An overdose of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) levels twice weekly. Should hypercalcemia develop, reduce the Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia

More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate therapy.

Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.

Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate on the progression of vascular or soft tissue calcification has not been determined.

Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

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6 ADVERSE REACTIONS

Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].

- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)

- In clinical studies, patients have occasionally experienced nausea during Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate therapy. (6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trial Experience

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.

In clinical studies, Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate has been generally well tolerated.

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.


Preferred Term


Total adverse reactions reported for Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate

N=167

N (%)


3 month, open label study of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate

N=69


Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate

N (%)


Placebo

N (%)


Nausea


6 (3.6)


6 (6.1)


0 (0)


0 (0)


Vomiting


4 (2.4)


4 (4.1)


0 (0)


0 (0)


Hypercalcemia


21 (12.6)


16 (16.3)


5 (7.2)


0 (0)


Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) concentration could reduce the incidence and severity of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Antigrippin-Maximum Lemon acetate is characterized by the potential of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate and most concomitant drugs. When administering an oral medication with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate.

- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)

- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate or consider monitoring blood levels of the drug. (7)

7.1 Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Antigrippin-Maximum Lemon acetate capsules contains Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate. Animal reproduction studies have not been conducted with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate, and there are no adequate and well controlled studies of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Antigrippin-Maximum Lemon Acetate Capsules contains Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate is not expected to harm an infant, provided maternal serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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10 OVERDOSAGE

Administration of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate acts as a phosphate binder. Its chemical name is Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:


Each white opaque/blue opaque capsule contains 667 mg of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Antigrippin-Maximum Lemon resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate.

14 CLINICAL STUDIES

Effectiveness of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate solid oral dosage form.

Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.

The patients received Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) levels are also presented.


* Ninety-one patients completed at least 6 weeks of the study.

ANOVA of difference in values at pre-study and study completion.

‡ Values expressed as mean ± SE.


Parameter


Pre-Study


Week 4*


Week 8


Week 12


p-value†


Phosphorus (mg/dL)‡


7.4 ± 0.17


5.9 ± 0.16


5.6 ± 0.17


5.2 ± 0.17


≤0.01


Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) (mg/dL)‡


8.9 ± 0.09


9.5 ± 0.10


9.7 ± 0.10


9.7 ± 0.10


≤0.01


There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate is shown in the Table 3.


* ANOVA of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) Acetate Capsules

667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.

NDC 0615-2303-39: Blistercards of 30 Capsules

NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules

STORAGE

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Antigrippin-Maximum Lemon (Calcium Gluconate Monohydrate) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Loratadine:


Antigrippin-Maximum Lemon (Loratadine) is a derivative of azatadine and a second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (histamine H1 antagonists) it lacks central nervous system depressing effects such as drowsiness.

Indication: A self-medication that is used alone or in combination with pseudoephedrine sulfate for the symptomatic relief of seasonal allergic rhinitis. Also used for the symptomatic relief of pruritus, erythema, and urticaria associated with chronic idiopathic urticaria in patients (not for children under 6 unless directed by a clincian).

Antigrippin-Maximum Lemon (Loratadine) is a long acting second generation antihistamine that is similar in structure to cyproheptadine and azatadine. The pharmacology of Antigrippin-Maximum Lemon (Loratadine) is similar to other antihistamines, but unlike other H1-blockers, loratidine is shown to exhibit competitive, specific, and selective antagonism of H1 receptors. The exact mechanism of this interaction is unknown, but disposition of the drug suggests that loratadine's prolonged antagonism of histamine may be due to the drug's slow dissociation from the receptor or the formation of the active metabolite, desloratadine. Antigrippin-Maximum Lemon (Loratadine) does not penetrate the CNS effectively and has a low affinity for CNS H1-receptors.

Rimantadine Hydrochloride:


INDICATIONS AND USAGE

Antigrippin-Maximum Lemon tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older).

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).

PROPHYLAXIS

In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 years of age and older), Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) prophylaxis have not been demonstrated for longer than 6 weeks.

TREATMENT

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) therapy should be considered for adults (17 years and older) who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) has been shown to reduce the duration of fever and systemic symptoms.

The following points should be considered before initiating treatment or prophylaxis with Antigrippin-Maximum Lemon (Rimantadine Hydrochloride):

  • Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Antigrippin-Maximum Lemon (Rimantadine Hydrochloride).

CONTRAINDICATIONS

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.

PRECAUTIONS

GENERAL

An increased incidence of seizures has been reported in patients with a history of epilepsy who received the related drug amantadine. In clinical trials of Antigrippin-Maximum Lemon, the occurrence of seizure-like activity was observed in a small number of patients with a history of seizures who were not receiving anticonvulsant medication while taking Antigrippin-Maximum Lemon (Rimantadine Hydrochloride). If seizures develop, Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) should be discontinued.

The safety and pharmacokinetics of rimantadine in hepatic insufficiency have only been evaluated after single dose administration. In a study of 14 subjects with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with hepatic insufficiency are treated with rimantadine.

Following multiple-dose administration of rimantadine, there were no clinically relevant differences in rimantadine systemic exposure between subjects with mild or moderate renal impairment compared to healthy subjects. In subjects with severe renal impairment, rimantadine systemic exposure increased by 81%, compared with healthy subjects. Because of the potential for increased accumulation of rimantadine metabolites in renally impaired subjects, caution should be exercised when these patients are treated with rimantadine.

Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)

Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) has not been shown to prevent such complications.

DRUG INTERACTIONS

Acetaminophen

Antigrippin-Maximum Lemon, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen (650 mg four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for rimantadine by approximately 11%.

Aspirin

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride), 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of rimantadine were reduced approximately 10% in the presence of aspirin.

Cimetidine

When a single 100 mg dose of Antigrippin-Maximum Lemon was administered with steady-state cimetidine (300 mg four times a day), there was no statistically significant differences in rimantadine Cmax or AUC between Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) alone and Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) in the presence of cimetdine.

Live Attenuated Influenza Vaccine (LAIV)

The concurrent use of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) with live attenuated intranasal influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) and Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) should be not administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY

Carcinogenesis

Oral administration of rimantadine to rats for 2 years at doses up to 100 mg/kg/d [approximately 11-14 times the maximum recommended human dose based on AUC] showed no evidence of increased tumor incidence.

Mutagenesis

No mutagenic effects were seen when rimantadine was evaluated in several standard assays for mutagenicity.

Impairment of Fertility

A reproduction study in male and female rats did not show detectable impairment of fertility at dosages up to 60 mg/kg/day.

PREGNANCY

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/d. At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), but evidence of a developmental abnormality in the form of a chance in the ratio of fetuses with 12 or 13 ribs were noted. This ratio is normally about 50:50 in a litter but was 80:20 after rimantadine treatment. However, in a repeat embryofetal toxicity study in rabbits at doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), this abnormality was not observed.

Nonteratogenic Effects

Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30, 60 and 120 mg/kg/d (1.7, 3.4 and 6.8 times the MRHD based on mg/m2). Maternal toxicity during gestation was noted at the two higher doses of rimantadine, and at the highest dose, 120 mg/kg/day, there was an increase in pup mortality during the first 2 to 4 days postpartum. Decreased fertility of the F1 generation was also noted for the two higher doses.

For these reasons, Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

NURSING MOTHERS

Antigrippin-Maximum Lemon should not be administered to nursing mothers because of the adverse effects noted in offspring of rats treated with rimantadine during the nursing period. Rimantadine is concentrated in rat milk in a dose-related manner: 2 to 3 hours following administration of rimantadine, rat breast milk levels were approximately twice those observed in the serum.

PEDIATRIC USE

In children (1 year to 16 years of age), Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is recommended for the prophylaxis of influenza A. The safety and effectiveness of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) in the treatment of symptomatic influenza infection in children (1 year to 16 years of age) have not been established. Prophylaxis studies with Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) have not been performed in children below the age of 1 year.

ADVERSE REACTIONS

In 1,027 patients treated with Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.

Incidence >1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.

Rimantadine

(n=1027)

Control

(n=986)

Nervous System
Insomnia 2.1% 0.9%
Dizziness 1.9% 1.1%
Headache 1.4% 1.3%
Nervousness 1.3% 0.6%
Fatigue 1.0% 0.9%
Gastrointestinal System
Nausea 2.8% 1.6%
Vomiting 1.7% 0.6%
Anorexia 1.6% 0.8%
Dry mouth 1.5% 0.6%
Abdominal Pain 1.4% 0.8%
Body as a Whole
Asthenia 1.4% 0.5%

Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.

Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.

Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride). In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.

Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1%.

Rimantadine

200 mg/day

(n=145)

Placebo

(n=143)

Amantadine

200 mg/day

(n=148)

Nervous System
Insomia 3.4% 0.7% 7.0%
Nervousness 2.1% 0.7% 2.8%
Impaired

Concentration


2.1%


1.4%


2.1%

Dizziness 0.7% 0.0% 2.1%
Depression 0.7% 0.7% 3.5%
Total % of subjects of adverse reactions

6.9%


4.1%


14.7%

Total % of subjects withdrawn due to adverse reactions

6.9%


3.4%`


14.0%

GERIATRIC USE

Approximately 200 patients over the age of 64 were evaluated for safety in controlled clinical trials with Antigrippin-Maximum Lemon (Rimantadine Hydrochloride). Geriatric subjects who received either 200 mg or 400 mg of rimantadine daily for 1 to 50 days experienced considerably more central nervous system and gastrointestinal adverse events than comparable geriatric subjects receiving placebo. Central nervous system events including dizziness, headache, anxiety, asthenia, and fatigue, occurred up to two times more often in subjects treated with rimantadine than in those treated with placebo. Gastrointestinal symptoms, particularly nausea, vomiting, and abdominal pain occurred at least twice as frequently in subjects receiving rimantadine than in those receiving placebo. The gastrointestinal symptoms appeared to be dose related. In patients over 65, the recommended dose is 100 mg, daily (see CLINCAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).

OVERDOSAGE

As with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.

DOSAGE AND ADMINISTRATION

FOR PROPHYLAXIS IN ADULTS AND CHILDREN

Adults

The recommended adult dose of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is 100 mg twice a day. Study durations ranged from 11 days to 6 weeks in adult and elderly patients. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and in elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects.

Children

  • Study duration ranged from 5 weeks to 6 weeks in pediatric subjects.
  • In children 1 year to 9 years of age, Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg.
  • For children 10 years of age or older, use the adult dose.

(see Directions for Compounding of an Oral Suspension from Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) Tablets to prepare an oral suspension for administration to children and patients with difficulty swallowing tablets).

Children

The safety and efficacy of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

FOR TREATMENT IN ADULTS

Adults

The recommended adult dose of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is 100 mg twice a day for 7 days. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects. Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms.

Children

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is not indicated for treatment of influenza in pediatric patients 16 years or younger.

Directions for the Compounding of an Oral Suspension from Antigrippin-Maximum Lemon Tablets (Final Concentration = 10 mg/mL)1

These directions are provided for use only during emergency situations, for patients who have difficulty swallowing tablets or where lower doses are needed. The pharmacist may compound a suspension (10 mg/mL) from Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) tablets, 100 mg using Ora-Sweet®.Ora-Sweet® is a registered trademark of Paddock Laboratories Other vehicles have not been studied.

To make an oral suspension (10 mg/mL) from 100 mg Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) tablets, you will need the following:

  • 100 mg tablets of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride)
  • Ora-Sweet® (a vehicle manufactured by Paddock Laboratories)
  • a graduated cylinder
  • a mortar and pestle
  • an Amber Glass or Polyethylene terephthalate plastic (PET) bottle
  • a funnel (optional)

Compounding Procedures

A 100 mg tablet of Antigrippin-Maximum Lemon is required for each 10 mL of compounded oral suspension to make a concentration of 10 mg/mL.

A compounded oral suspension is stable for 14 days. Therefore, the maximum amount of oral suspension that can be dispensed to a patient should not exceed a 14 day supply.

Step A: Guidance for how to determine the Number of Tablets and Total Volume needed to compound a 10 mg/mL oral suspension for each patient

  • Verify the prescribed dose is correct.
  • Calculate the mg amount of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) needed for the duration of therapy.

    (Daily Dose) × (Number of days) = (mg of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride))

    For example, 75 mg/day × 10 days = 750 mg

  • Round up the mg of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) amount to the next 100 mg designation.

    For example, Round up 750 mg to 800 mg

  • Calculate the Number of 100 mg tablets that are required for the compounded oral suspension.

    (Rounded mg of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride)) ÷ (100 mg/tablet) = (Number of tablets)

    For example, 800 mg ÷100 mg/tablet = 8 tablets

  • Calculate the Total Volume of compounded oral suspension (10 mg/mL) (Rounded mg of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride)) ÷ (10 mg/mL) = (Total Volume)

    For example, 800 mg ÷ 10 mg/mL = 80 mL


Step B: Once the total Number of Tablets and Volume are determined then follow the procedures below for compounding the oral suspension (10 mg/mL) from Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) tablets 100 mg

Verify your calculations before you begin to compound an oral suspension.

A 100 mg tablet of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) is required for each 10 mL's of compounded oral suspension to make a concentration of 10 mg/mL.

  • Place the required number of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) 100 mg tablets into a clean mortar of sufficient size to contain the tablets and volume of vehicle, Ora-Sweet® used in Step 3.
  • Grind the tablets and triturate to a fine powder using a pestle. Powder on the sides of the mortar or pestle should be removed using a spatula and incorporated into the trituration throughout the process.
  • Slowly add approximately one-third (1/3) of the total volume of vehicle to the mortar while triturating until a uniform suspension is achieved.
  • Transfer the suspension to an amber glass or a PET plastic bottle. Other types of bottles, such as non-PET plastic or uncolored bottles, have not been evaluated and should not be used. A funnel may be used to eliminate any spillage.
  • Slowly add the second one-third (1/3) of the total volume of vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the contents into the bottle.
  • Repeat the rinsing (Step 5) with the remaining one-third (1/3) of the vehicle, transferring the remaining contents to the fullest extent possible. Verify that the suspension is at the desired total volume or add additional vehicle if needed.
  • Close the bottle using a child-resistant cap.
  • Shake well to ensure homogeneous suspension. (Note: The active drug, rimantadine HCl readily dissolves in the specified vehicle. The suspension is caused by some of the inert ingredients of Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) tablets 100 mg which are insoluble in this vehicle.)
  • Include an ancillary label on the bottle indicating "Shake Gently Before Use." This compounded suspension should be gently shaken prior to administration to minimize the tendency for air entrapment with the Ora-Sweet® preparation. The need to shake the compounded oral suspension gently prior to administration should be reviewed with the parent or guardian when the suspension is dispensed.
  • Provide an oral dosing device (a graduated oral syringe or spoon) that will measure the prescribed dose (in mL). If possible, mark or highlight the graduation corresponding to the appropriate dose on the oral syringe or spoon for each patient.
  • Include an Expiration Date label according to storage condition and a "Discard any Unused Portion" label to the bottle. Instruct the parent or guardian that any remaining material following completion of therapy or after the expiration date on the label must be discarded.

STORAGE OF THE PHARMACY-COMPOUNDED SUSPENSION

Room Temperature: Stable for 14 days when stored in ambient room temperature conditions. Other storage conditions have not been studied.

Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicle, which was placed in amber glass and PET plastic bottles at 25°C (77°F). Stability studies have not been conducted with other vehicles or bottle types.

HOW SUPPLIED

Antigrippin-Maximum Lemon (Rimantadine Hydrochloride) Tablets, 100 mg-Each orange, oval, film-coated, convex-faced tablet is debossed with a "G" on one side and "1911" on the other side.

Bottles of 100 NDC 0115-1911-01
Bottles of 500 NDC 0115-1911-02

Store at 20°C to 25°C (68° to 77°F)

REFERENCES

  • Belshe RB, Burk B, Newman F, et al. J. Infect. Dis. 1989; 159(3):430-435.
  • Sim IS, Cerruti RL, Connell EV. J. Resp. Dis. 1989(Suppl): S46-S51.
  • Hayden FG, Belshe RB, Clover RD, et al. N.Engl. J. Med. 1989; 321(25), 1696-1702.
  • Hall CB, Dolin R, Gala CL, et al. Pediatrics 1987; 80(2): 275-282.
  • Thompson J, Fleet W, Lawrence E et al. J.Med. Virol. 1987; 21(3): 249-255.
  • Belshe RB, Smith MH, Hall CB, et al. J. Virol.1988; 62(5): 1508-1512.
  • Casey DE. N Engl J Med. 1978; 298(9):516.
  • Berkowitz CD. J. Pediatri. 1979; 95(1): 144-145.
  • Hayden FG, Sperber SJ, Belshe RB, et al. Antimicrob Agents Chemother. 1991; 35(9): 1741-1747
  • Deyde VM, Xu X, Bright RA, et al. J Infect Dis. 2007; 196(2): 249-257.
  • CDC MMWR Morb Mortal Wkly Rep. 2009; 58(16): 433-435.

Dist. by:

Global Pharmaceuticals

Division of IMPAX Laboratories, Inc.

Philadelphia, PA 19124 USA

Rev. 04/2010

224-03

Rimantadine 100mg Tablet

Chemical Structure

Vitamin C (Ascorbic Acid):


Pharmacological action

Antigrippin-Maximum Lemon ) (vitamin c) is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) has antioxidant properties.

With intravaginal application of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).

Pharmacokinetics

After oral administration Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.

The concentration of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in blood plasma in normal amounts to approximately 10-20 mg / ml.

The concentration of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.

Plasma protein binding is about 25%.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.

Why is Antigrippin-Maximum Lemon ) prescribed?

For systemic use of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) RiteMED Phils: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Dosage and administration

This medication administered orally, IM, IV, intravaginally.

For the prevention of deficiency conditions Antigrippin-Maximum Lemon ) dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.

For intravaginal used Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) drugs in appropriate dosage forms.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) side effects, adverse reactions

CNS: headache, fatigue, insomnia.

Digestive system: stomach cramps, nausea and vomiting.

Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.

Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.

Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.

Antigrippin-Maximum Lemon ) contraindications

Increased sensitivity to Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)).

Using during pregnancy and breastfeeding

The minimum daily requirement of Antigrippin-Maximum Lemon ) in the II and III trimester of pregnancy is about 60 mg.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)), which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in high doses, except in cases where the expected benefit outweighs the potential risk.

The minimum daily requirement during lactation (breastfeeding) is 80 mg. Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) is excreted in breast milk. A mother's diet that contains adequate amounts of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)), is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)), except when the expected benefit outweighs the potential risk.

Special instructions

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

Patients with high content body iron should apply Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in minimal doses.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.

The use of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in high doses can cause exacerbation of sickle cell anemia.

Data on the diabetogenic action of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) are contradictory. However, prolonged use of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) should periodically monitor your blood glucose levels.

It is believed that the use of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in patients with advanced cancer.

Absorption of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) decreased while use of fresh fruit or vegetable juices, alkaline drinking.

Antigrippin-Maximum Lemon ) drug interactions

In an application with barbiturates, primidone increases the excretion of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in blood plasma.

In an application of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) with iron preparations Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)), due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) by about a third.

Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) increases the excretion of iron in patients receiving deferoxamine. In the application of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with Antigrippin-Maximum Lemon (Vitamin C (Ascorbic Acid)) 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

Antigrippin-Maximum Lemon ) in case of emergency / overdose

Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).

Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).

When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.

Antigrippin-Maximum Lemon 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.


Antigrippin-Maximum Lemon 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.


Antigrippin-Maximum Lemon 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.


Antigrippin-Maximum Lemon 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.


Antigrippin-Maximum Lemon 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."WAL ITIN (LORATADINE) TABLET [WALGREEN COMPANY]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FEVERALL INFANTS (ACETAMINOPHEN) SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Antigrippin-Maximum Lemon?

Depending on the reaction of the Antigrippin-Maximum Lemon after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Antigrippin-Maximum Lemon 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 Antigrippin-Maximum Lemon 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 Antigrippin-Maximum Lemon, 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 Antigrippin-Maximum Lemon 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

Visitor reported side effects

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Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

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Visitor reported age

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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