DRUGS & SUPPLEMENTS

Amalar Forte

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Amalar Forte uses

Amalar Forte consists of Pyrimethamine, Sulfadoxine.

Pyrimethamine:


DESCRIPTION

Amalar Forte (Pyrimethamine) (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg Amalar Forte (Pyrimethamine) and the inactive ingredients corn and potato starch, lactose, and magnesium stearate.

Amalar Forte (Pyrimethamine), known chemically as 5-(4- chlorophenyl)-6-ethyl-2, 4-pyrimidinediamine, has the following structural formula:

C12H13CIN4

Mol. Wt. 248.71

Structural Formula

CLINICAL PHARMACOLOGY

Amalar Forte (Pyrimethamine) is well absorbed with peak levels occurring between 2 to 6 hours following administration. It is eliminated slowly and has a plasma half-life of approximately 96 hours. Amalar Forte (Pyrimethamine) is 87% bound to human plasma proteins.

Microbiology: Amalar Forte (Pyrimethamine) is a folic acid antagonist and the rationale for its therapeutic action is based on the differential requirement between host and parasite for nucleic acid precursors involved in growth. This activity is highly selective against Toxoplasma gondii.

The action of Amalar Forte (Pyrimethamine) against Toxoplasma gondii is greatly enhanced when used in conjunction with sulfonamides. This was demonstrated by Eyles and Coleman1 in the treatment of experimental toxoplasmosis in the mouse. Jacobs et al2 demonstrated that combination of the 2 drugs effectively prevented the development of severe uveitis in most rabbits following the inoculation of the anterior chamber of the eye with toxoplasma.

INDICATIONS AND USAGE

Treatment of Toxoplasmosis: Amalar Forte (Pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

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CONTRAINDICATIONS

Use of Amalar Forte (Pyrimethamine) is contraindicated in patients with known hypersensitivity to Amalar Forte (Pyrimethamine) or to any component of the formulation. Use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.

WARNINGS

The dosage of Amalar Forte (Pyrimethamine) required for the treatment of toxoplasmosis has a narrow therapeutic window. If signs of folate deficiency develop, reduce the dosage or discontinue the drug according to the response of the patient. Folinic acid (leucovorin) should be administered in a dosage of 5 to 15 mg daily (orally, IV, or IM) until normal hematopoiesis is restored. Data in 2 humans indicate that Amalar Forte (Pyrimethamine) may be carcinogenic; a 51-year-old female who developed chronic granulocytic leukemia after taking Amalar Forte (Pyrimethamine) for 2 years for toxoplasmosis3 and a 56-year-old patient who developed reticulum cell sarcoma after 14 months of Amalar Forte (Pyrimethamine) for toxoplasmosis.4

Amalar Forte (Pyrimethamine) has been reported to produce a significant increase in the number of lung tumors in mice when given intraperitoneally at doses of 25 mg/kg.5

Amalar Forte (Pyrimethamine) should be kept out of the reach of infants and children as they are extremely susceptible to adverse effects from an overdose. Deaths in pediatric patients have been reported after accidental ingestion.

PRECAUTIONS

General: A small "starting" dose for toxoplasmosis is recommended in patients with convulsive disorders to avoid the potential nervous system toxicity of Amalar Forte (Pyrimethamine). Amalar Forte (Pyrimethamine) should be used with caution in patients with impaired renal or hepatic function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism, or pregnancy, and those receiving therapy, such as phenytoin, affecting folate levels.

Information for Patients: Patients should be warned that at the first appearance of a skin rash they should stop use of Amalar Forte (Pyrimethamine) and seek medical attention immediately. Patients should also be warned that the appearance of sore throat, pallor, purpura, or glossitis may be early indications of serious disorders which require treatment with Amalar Forte (Pyrimethamine) to be stopped and medical treatment to be sought. Women of childbearing potential who are taking Amalar Forte (Pyrimethamine) should be warned against becoming pregnant Patients should be warned to keep Amalar Forte (Pyrimethamine) out of the reach of children. Patients should be advised not to exceed recommended doses. Patients should be warned that if anorexia and vomiting occur, they may be minimized by taking the drug with meals. Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in all patients.

Laboratory Tests: In patients receiving high dosage, semiweekly blood counts, including platelet counts, should be performed.

Drug Interactions: Amalar Forte (Pyrimethamine) may be used with sulfonamides, quinine and other antimalarials, and with other antibiotics. However, the concomitant use of other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim- sulfamethoxazole combinations, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), while the patient is receiving Amalar Forte (Pyrimethamine), may increase the risk of bone marrow suppression. If signs of folate deficiency develop, Amalar Forte (Pyrimethamine) should be discontinued. Folinic acid (leucovorin) should be administered until normal hematopoiesis is restored. Mild hepatotoxicity has been reported in some patients when lorazepam and Amalar Forte (Pyrimethamine) were administered concomitantly.

Carcinogenesis, Mutagenesis, Impairment of Fertility: See WARNINGS section for information on carcinogenesis.

Mutagenesis: Amalar Forte (Pyrimethamine) has been shown to be nonmutagenic in the following in vitro assays: the Ames point mutation assay, the Rec assay, and the E. coli WP2 assay. It was positive in the L5178Y/ TK +/- mouse lymphoma assay in the absence of exogenous metabolic activation.6 Human blood lymphocytes cultured in vitro had structural chromosome aberrations induced by Amalar Forte (Pyrimethamine). In vivo, chromosomes analyzed from the bone marrow of rats dosed with Amalar Forte (Pyrimethamine) showed an increased number of structural and numerical aberrations.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Amalar Forte (Pyrimethamine) has been shown to be teratogenic in rats when given in oral doses 2.5 times the human dose for treatment of toxoplasmosis. At these doses in rats, there was a significant increase in abnormalities such as cleft palate, brachygnathia, oligodactyly, and microphthalmia. Amalar Forte (Pyrimethamine) has also been shown to produce terata such as meningocele in hamsters and cleft palate in miniature pigs when given in oral doses 5 times the human dose for the treatment of toxoplasmosis.

There are no adequate and well-controlled studies in pregnant women. Amalar Forte (Pyrimethamine) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Concurrent administration of folinic acid is strongly recommended when used during pregnancy.

Nursing Mothers: Amalar Forte (Pyrimethamine) is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Amalar Forte (Pyrimethamine) and from concurrent use of a sulfonamide with Amalar Forte (Pyrimethamine) for treatment of some patients with toxoplasmosis, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: See DOSAGE AND ADMINISTRATION section.

Geriatric Use: Clinical studies of Amalar Forte (Pyrimethamine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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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ADVERSE REACTIONS

Hypersensitivity reactions, occasionally severe (such as Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when Amalar Forte (Pyrimethamine) is administered concomitantly with a sulfonamide. Consult the complete prescribing information for the relevant sulfonamide for sulfonamide-associated adverse events. With doses of Amalar Forte (Pyrimethamine) used for the treatment of toxoplasmosis, anorexia and vomiting may occur. Vomiting may be minimized by giving the medication with meals; it usually disappears promptly upon reduction of dosage. Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm.

Hematologic effects, however, may also occur at low doses in certain individuals.

Pulmonary eosinophilia has been reported rarely.

OVERDOSAGE

Following the ingestion of 300 mg or more of Amalar Forte (Pyrimethamine), gastrointestinal and/or central nervous system signs may be present, including convulsions. The initial symptoms are usually gastrointestinal and may include abdominal pain, nausea, severe and repeated vomiting, possibly including hematemesis. Central nervous system toxicity may be manifest by initial excitability, generalized and prolonged convulsions which may be followed by respiratory depression, circulatory collapse, and death within a few hours. Neurological symptoms appear rapidly (30 minutes to 2 hours after drug ingestion), suggesting that in gross overdosage Amalar Forte (Pyrimethamine) has a direct toxic effect on the central nervous system.

The fatal dose is variable, with the smallest reported fatal single dose being 375 mg. There are, however, reports of pediatric patients who have recovered after taking 375 to 625 mg.

There is no specific antidote to acute Amalar Forte (Pyrimethamine) poisoning. In the event of overdosage, symptomatic and supportive measures should be employed. Gastric lavage is recommended and is effective if earned out very soon after drug ingestion. Parenteral diazepam may be used to control convulsions. Folinic acid should be administered within 2 hours of drug ingestion to be most effective in counteracting the effects on the hematopoietic system. Due to the long half-life of Amalar Forte (Pyrimethamine), daily monitoring of peripheral blood counts is recommended for up to several weeks after the overdose until normal hematologic values are restored.

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DOSAGE AND ADMINISTRATION

For Treatment of Toxoplasmosis: The dosage of Amalar Forte (Pyrimethamine) for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.

The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks. The pediatric dosage of Amalar Forte (Pyrimethamine) is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with Amalar Forte (Pyrimethamine).

HOW SUPPLIED:

White, scored tablets containing 25 mg Amalar Forte (Pyrimethamine), imprinted with “DARAPRIM” and “A3A" in bottles of 100 (NDC 69413-330-10) and bottles of 30 (NDC 69413-330-30).

Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light

REFERENCES

  • Eyles DE, Coleman N. Synergistic effect of sulfadiazine and Amalar Forte (Pyrimethamine) against experimental toxoplasmosis in the mouse. Antibiot Chemother 1953;3:483-490.
  • Jacobs L, Melton ML, Kaufman HE. Treatment of experimental ocular toxoplasmosis. Arch Ophthalmol. 1964;71:111 -118.
  • Jim RTS, Elizaga FV. Development of chronic granulocytic leukemia in a patient treated with Amalar Forte (Pyrimethamine). Hawaii Med J. 1977;36:173-176.
  • Sadoff L. Antimalarial drugs and Burkitt's lymphoma. Lancet. 1973;2:1262-1263.
  • Bahna L. Amalar Forte (Pyrimethamine). LARC Monogr Eval Carcinog Risk Chem. 1977;13:233-242.
  • Clive D, Johnson KO, Specter JKS, et al. Validation and characterization of the L5178Y/TK +/- mouse lymphoma mutagen assay system. Mut Res. 1979;59:61-108.

Distributed by:

Vyera Pharmaceuticals LLC New York, New York 10016

004967-PI-005

018942

Rev. 8/2017

VYERA

PHARMACEUTICALS

NDC 69413-330-10

Amalar Forte (Pyrimethamine) ®

(pyrimethamine) 25mg tablets

Each scored tablet contains

25 mg

Rx only 100 Tablets

018939

LOT

EXP

VYERA

PHARMACEUTICALS

NDC 69413-330-30

Amalar Forte (Pyrimethamine) ®

(pyrimethamine) 25mg tablets

Each scored tablet contains

25 mg

Rx only 30 Tablets

018940

LOT

EXP

VYERA

PHARMACEUTICALS

NDC 69413-330-06

Amalar Forte (Pyrimethamine) ®

(pyrimethamine) 25mg tablets

Each scored tablet contains

25 mg

Rx only 6 Tablets

PATIENT SAMPLE

NOT FOR SALE

018941

LOT

EXP

Sulfadoxine:


A long acting sulfonamide that is used, usually in combination with other drugs, for respiratory, urinary tract, and malarial infections.

Indication: Amalar Forte (Sulfadoxine) is used in combination with pyrimethamine for the treatment or prevention of malaria. It can also be used to treat various infections in livestock as well. Sulfadoxine and pyrimethamine is indicated for the treatment of Plasmodium falciparum malaria in those patients in whom chloroquine resistance is suspected.

Amalar Forte (Sulfadoxine) helps inhibit the enzyme dihydropteroate synthetase which is an enzyme necessary in the conversion of PABA to folic acid. As folic acid is vital to the synthesis, repair, and methylation of DNA which is vital to cell growth in Plasmodium falciparum. With this vital nutrient lacking, the parasite has difficulty in reproducing.

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Amalar Forte pharmaceutical active ingredients containing related brand and generic drugs:

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.


Amalar Forte 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.


Amalar Forte 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.


Amalar Forte Anatomical Therapeutic Chemical 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.


Amalar Forte pharmaceutical companies:

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.


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References

  1. Dailymed."DARAPRIM (PYRIMETHAMINE) TABLET [VYERA PHARMACEUTICALS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PYRIMETHAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "pyrimethamine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Amalar Forte?

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

One visitor reported useful

How is the drug Amalar Forte useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
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Not useful1
100.0%

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

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