DRUGS & SUPPLEMENTS
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Medication: Alminth

Alminth uses

  1. 1 INDICATIONS AND USAGE
  2. 2 DOSAGE AND ADMINISTRATION
  3. 3 DOSAGE FORMS AND STRENGTHS
  4. 4 CONTRAINDICATIONS
  5. 5 WARNINGS AND PRECAUTIONS
  6. 6 ADVERSE REACTIONS
  7. 7 DRUG INTERACTIONS
  8. 8 USE IN SPECIFIC POPULATIONS
  9. 10 OVERDOSAGE
  10. 11 DESCRIPTION
  11. 12 CLINICAL PHARMACOLOGY
  12. 13 NONCLINICAL TOXICOLOGY
  13. 16 HOW SUPPLIED/STORAGE AND HANDLING
  14. 17 PATIENT COUNSELING INFORMATION
  15. PRINCIPAL DISPLAY PANEL - NDC: 52054-550-22 - 200 MG 2-COUNT BOTTLE LABEL
  16. PRINCIPAL DISPLAY PANEL - NDC: 52054-550-28 - 200 MG 28-COUNT BOTTLE LABEL
  17. PRINCIPAL DISPLAY PANEL - NDC: 52054-551-22 - 200 MG WALLET CARD (FRONT)
  18. PRINCIPAL DISPLAY PANEL - NDC: 52054-551-22 - 200 MG WALLET CARD (BACK)

1 INDICATIONS AND USAGE

Alminth is an anthelmintic drug indicated for:

  • Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
  • Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. (1.2)

1.1 Neurocysticercosis

Alminth is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

1.2 Hydatid Disease

Alminth is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

2 DOSAGE AND ADMINISTRATION

Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily. Alminth tablets and Alminth chewable tablets should be taken with food. (2)

  • Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. (2)
  • Neurocysticercosis: 8 to 30 days. (2)

See additional important information in the Full Prescribing Information. (2)

2.1 Dosage

Dosing of Alminth will vary depending upon the indication. Alminth tablets may be crushed or chewed and swallowed with a drink of water. Alminth chewable tablets are also available for children and patients who may experience swallowing difficulties. Alminth tablets and Alminth chewable tablets should be taken with food [see Clinical Pharmacology (12.3)].

 Indication  Patient Weight  Dose  Duration
 Hydatid Disease  60 kg or greater  400 mg twice daily, with meals  28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles
 Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)
 Neurocysticercosis  60 kg or greater  400 mg twice daily, with meals  8 to 30 days
 Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

2.2 Concomitant Medication to Avoid Adverse Reactions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions ].

2.3 Monitoring for Safety Before and During Treatment

  • Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with Alminth in all patients [see Warnings and Precautions (5.1)].
  • Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with Alminth in all patients [see Warnings and Precautions (5.5)].
  • Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)].

3 DOSAGE FORMS AND STRENGTHS

  • Tablet: 200 mg
  • Chewable Tablet: 200 mg
  • Tablet: 200 mg (3)
  • Chewable Tablet: 200 mg (3)

4 CONTRAINDICATIONS

Alminth is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.

Patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.

5 WARNINGS AND PRECAUTIONS

  • Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue Alminth if clinically significant changes in blood counts occur.
  • Teratogenic Effects: Obtain pregnancy test in women of reproductive potential prior to therapy and avoid usage in pregnant women except in clinical circumstances where no alternative management is appropriate. Discontinue therapy if pregnancy occurs and apprise patient of potential hazard to the fetus. (5.2)
  • Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. (5.3)
  • Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. (5.4)
  • Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on Alminth therapy and discontinue if clinically significant elevations occur. (5.5)

5.1 Bone Marrow Suppression

Fatalities associated with the use of Alminth have been reported due to granulocytopenia or pancytopenia Alminth may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with Alminth in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue Alminth if clinically significant decreases in blood cell counts occur.

5.2 Teratogenic Effects

Alminth may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing Alminth to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of Alminth therapy and for one month after end of therapy. Immediately discontinue Alminth if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations ].

5.3 Risk of Neurologic Symptoms in Neurocysticercosis

Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain.

5.4 Risk of Retinal Damage in Patients with Retinal Neurocysticercosis

Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by ALBENZA-induced death of the parasite.

5.5 Hepatic Effects

In clinical trials, treatment with Alminth has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [see Adverse Reactions ].

Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing Alminth therapy based on individual patient circumstances. Restarting Alminth treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further Alminth usage. Perform laboratory tests frequently if Alminth treatment is restarted.

Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [see Warnings and Precautions (5.1)]. Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.

5.6 Unmasking of Neurocysticercosis in Hydatid Patients

Undiagnosed neurocysticercosis may be uncovered in patients treated with Alminth for other conditions. Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy.

6 ADVERSE REACTIONS

  • Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever.
  • Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Amedra Pharmaceuticals LLC at 1-888-894-6528 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials 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.

The adverse reaction profile of Alminth differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to ALBENZA.

 Adverse Reaction  Hydatid Disease  Neurocysticercosis
 Gastrointestinal
 Abdominal Pain  6  0
 Nausea  4  6
 Vomiting  4  6
 General disorders and administration site conditions
 Fever  1  0
 Investigations
 Elevated Hepatic Enzymes  16  less than 1
 Nervous system disorders
 Dizziness  1  less than 1
 Headache  1  11
 Meningeal Signs  0  1
 Raised Intracranial Pressure  0  2
 Vertigo  1  less than 1
 Skin and subcutaneous tissue disorders
 Reversible Alopecia  2  less than 1

The following adverse events were observed at an incidence of less than 1%:

Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [see Warnings and Precautions (5.1)].

Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALBENZA. 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.

Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.

Eye Disorders: Vision blurred.

Gastrointestinal Disorders: Diarrhea.

General System Disorders: Asthenia.

Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.

Nervous System Disorders: Somnolence, convulsion.

Renal and Urinary Disorders: Acute renal failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.

7 DRUG INTERACTIONS

  • Dexamethasone: Steady-state trough concentrations of Alminth sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of albendazole.
  • Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of Alminth sulfoxide by about 50% in healthy subjects. (7.2)
  • Cimetidine: Increased Alminth sulfoxide concentrations in bile and cystic fluid by about 2-fold in hydatid cyst patients. (7.3)
  • Theophylline: Alminth induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. (5.5, 7.4)

7.1 Dexamethasone

Steady-state trough concentrations of Alminth sulfoxide were about 56% higher when 8 mg dexamethasone was co-administered with each dose of Alminth (15 mg/kg/day) in 8 neurocysticercosis patients.

7.2 Praziquantel

In the fed state, praziquantel increased mean maximum plasma concentration and area under the curve of Alminth sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given Alminth alone. Mean Tmax and mean plasma elimination half-life of Alminth sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with Alminth (400 mg).

7.3 Cimetidine

Alminth sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with Alminth (20 mg/kg/day) alone (n = 12). Alminth sulfoxide plasma concentrations were unchanged 4 hours after dosing.

7.4 Theophylline

Following a single dose of Alminth (400 mg), the pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged. Alminth induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies of Alminth administration in pregnant women. Alminth should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Alminth should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing Alminth to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of Alminth therapy and for one month after end of therapy. If a patient becomes pregnant while taking this drug, Alminth should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Alminth has been shown to be teratogenic in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m2, respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m2) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2), administered during gestation days 6 to 15.

8.3 Nursing Mothers

Alminth is excreted in animal milk. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Alminth is administered to a nursing woman.

8.4 Pediatric Use

Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of Alminth in children appears to be similar to that in adults.

8.5 Geriatric Use

In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of Alminth is different from that of younger patients.

8.6 Patients with Impaired Renal Function

The pharmacokinetics of Alminth in patients with impaired renal function has not been studied.

8.7 Patients with Extra-Hepatic Obstruction

In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of Alminth sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of Alminth sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent Alminth were measurable in only 1 of 5 patients.

10 OVERDOSAGE

In case of overdosage, symptomatic therapy and general supportive measures are recommended.

11 DESCRIPTION

Alminth (albendazole) is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure:

Alminth is a white to yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Alminth is practically insoluble in alcohol and in water.

Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole.

Inactive ingredients consist of: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, and starch.

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of albendazole.

Inactive ingredients consist of: lactose monohydrate, microcrystalline cellulose, D-mannitol, sodium starch glycolate, povidone, N-C Wild Berry Type Flavor, magnesium stearate, crospovidone, polyvinyl acetate, sucralose, colloidal silicone dioxide, sodium lauryl sulfate, D&C Red #30/Helendon Pink Aluminum Lake.

methyl 5-(propylthio)-2-benzimidazolecarbamate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alminth is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4)].

12.3 Pharmacokinetics

Absorption

Alminth is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Alminth concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, Alminth sulfoxide. Oral bioavailability appears to be enhanced when Alminth is coadministered with a fatty meal (estimated fat content 40 grams) as evidenced by higher (up to 5-fold on average) plasma concentrations of Alminth sulfoxide as compared to the fasted state.

Maximal plasma concentrations of Alminth sulfoxide were achieved 2 hours to 5 hours after dosing and were on average 1310 ng/mL (range 460 ng/mL to 1580 ng/mL) following oral doses of Alminth (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of Alminth sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal (fat content 43.1 grams). The mean apparent terminal elimination half-life of Alminth sulfoxide ranged from 8 hours to 12 hours in 25 healthy subjects, as well as in 14 hydatid and 8 neurocysticercosis patients.

In a study conducted in 113 fed and 117 fasted healthy subjects, Alminth chewable tablets were bioequivalent to Alminth tablets following single 400 mg oral doses of albendazole. In this study, the average time to reach the maximal plasma concentrations of Alminth sulfoxide was 4.5 hours (range 2 to 10 hours) with a fatty meal (fat content 60 grams) and at 3 hours (range 1 to 5 hours) in the fasted state. Following administration of Alminth chewable tablets, average maximal plasma concentrations of Alminth sulfoxide were 804 ng/mL (range 202 to 2244 ng/mL) and 218 ng/mL (range 54 to 592 ng/mL) in the fed and fasted states, respectively. The apparent elimination half-life of Alminth sulfoxide was comparable between Alminth chewable tablets and Alminth tablets when both were given either under fed or fasted conditions.

Following 4 weeks of treatment with Alminth (200 mg three times daily), 12 patients’ plasma concentrations of Alminth sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that Alminth may induce its own metabolism.

Distribution

Alminth sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively.

Metabolism and Excretion

Alminth is rapidly converted in the liver to the primary metabolite, Alminth sulfoxide, which is further metabolized to Alminth sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, Alminth has not been detected in human urine. Urinary excretion of Alminth sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of Alminth sulfoxide similar to those achieved in plasma.

Specific Populations

Pediatrics

Following single-dose administration of 200 mg to 300 mg (approximately 10 mg/kg) Alminth to 3 fasted and 2 fed pediatric patients with hydatid cyst disease (age range 6 to 13 years), Alminth sulfoxide pharmacokinetics were similar to those observed in fed adults.

Geriatrics

Although no studies have investigated the effect of age on Alminth sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects.

12.4 Microbiology

Mechanism of Action

Alminth binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and also depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies.

Mechanism of Resistance

Parasitic resistance to Alminth is caused by changes in amino acids that result in changes in the β-tubulin protein. This causes reduced binding of the drug to β-tubulin.

In the specified treatment indications Alminth appears to be active against the larval forms of the following organisms:

Echinococcus granulosus

Taenia solium

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies were conducted in mice and rats.

No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis).

In genotoxicity tests, Alminth was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, Alminth produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation.

Alminth did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m2).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole.

Bottles of 2 Tablets       NDC 52054-550-22

Bottles of 28 Tablets     NDC 52054-550-28

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of albendazole.

2 Tablets in 1 Blister Pack   NDC 52054-551-22

6 Tablets in 1 Blister Pack; 2 Blister Packs in 1 Carton      NDC 52054-551-12

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised that:

  • Some people, particularly children, may experience difficulties swallowing the Alminth tablets whole. Alminth chewable tablet is available for children and patients who may be unable to swallow a tablet.
  • Take Alminth with food.
  • Alminth may cause fetal harm, therefore, obtain a pregnancy test in women of reproductive potential prior to initiating therapy.
  • Advise women of reproductive potential to use effective birth control while on Alminth and for one month after completing treatment.
  • During Alminth therapy, monitor blood counts and liver enzymes every 2 weeks because of the possibility of harm to the liver or bone marrow.

Alminth and TILTAB are registered trademarks of GlaxoSmithKline, used with permission.

Distributed by:

Amedra Pharmaceuticals LLC

Horsham, PA 19044

LB# 799-04

PRINCIPAL DISPLAY PANEL - NDC: 52054-550-22 - 200 mg 2-count Bottle Label

Alminth 2 count

PRINCIPAL DISPLAY PANEL - NDC: 52054-550-28 - 200 mg 28-count Bottle Label

Alminth 28 count

PRINCIPAL DISPLAY PANEL - NDC: 52054-551-22 - 200 mg Wallet Card

Alminth 2 count (Front)

PRINCIPAL DISPLAY PANEL - NDC: 52054-551-22 - 200 mg Wallet Card

Alminth 2 count (Back)
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Alminth pharmaceutical active ingredients containing related brand and generic drugs, medications or other health care products:

infoActive 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. The below information contains the active ingredients of Alminth.


Alminth available forms, composition, doses:

infoForm 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. The below information contains the forms, composition, doses of Alminth.


Alminth destination | category:

infoDestination 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. The below information contains the destination, category of Alminth.


Alminth indications and usages, anatomical therapeutic chemical and diseases classification codes:

infoA 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. The below information contains the Indications and usages, anatomical therapeutic chemical and diseases classification codes of Alminth.


Alminth pharmaceutical companies, researchers, developers, manufacturers, distributors and suppliers:

infoPharmaceutical 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. The below information contains the information about Pharmaceutical companies and Researchers involved in the development of Alminth.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Alminth?

Depending on the reaction of the Alminth after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alminth 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 Alminth 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.

Review

sDrugs.com conducted a study on Alminth, 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 Alminth 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.

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

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