Umactin BD Capsule 75mg+25mg

Product Information

UMACTIN

Umactin®

Nitrofurantoin

Presentation

Umactin-50 capsule: Opaque yellow cap imprinted with “UMC” and opaque white body imprinted with “50” capsule; each capsule

contains Nitrofurantoin (as macrocrystal) USP 50mg.

Umactin-100 capsule: Opaque yellow cap imprinted with “UMC” and opaque white body imprinted with “100” capsule; each capsule

contains Nitrofurantoin (as macrocrystal) USP 100mg.

Umactin-BD 100 capsule: Opaque blue cap imprinted with “100” and opaque yellow body imprinted with “UMB” capsule; each capsule

contains Nitrofurantoin (macrocrystals) USP 25mg and Nitrofurantoin Monohydrate USP equivalent to Nitrofurantoin 75mg.

Umactin oral suspension: Opaque yellow, lemon and blueberry flavoured suspension; each 5ml suspension contains Nitrofurantoin

Monohydrate USP equivalent to Nitrofurantoin 25mg.

Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either

spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli,

enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.

Dosage and administration

   11 [https://unimedunihealth.com/wp-content/uploads/2014/05/11-184x300.jpg]

[https://unimedunihealth.com/wp-content/uploads/2014/05/11.jpg]

Contra-indications, warnings etc.

Contra-indications: Nitrofurantoin are contra-indicated in patients suffering from renal dysfunction with a creatinine clearance

of less than 60 ml/minute or elevated serum creatinine, in infants under 3 months of age as well as pregnant patients at term

(during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant

due to immature erythrocyte enzyme systems and in patients with a known hypersensitivity to nitrofurantoin or other nitrofurans.

Warnings and precautions: Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally

nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.  Since pre-existing

conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic

dysfunction, neurological disorders, and allergic diathesis. Peripheral neuropathy which may become severe or irreversible has

occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement

(paraesthesiae). Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance,

debilitating conditions and vitamin B (particularly folate) deficiency. Chronic pulmonary reactions can develop insidiously, and

may occur more commonly in elderly patients. Close monitoring of pulmonary conditions of patients receiving long-term therapy is

warranted.  Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate

dehydrogenase deficiency.  Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of

dosage. 

Use in pregnancy and lactation: Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in

extensive clinical use since 1952, and its suitability in human pregnancy has been well documented. The drug should be used at the

lowest dose as appropriate for a specific indication, only after careful assessment.  Nitrofurantoin is however contra-indicated

in infants under 3 months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of

the infants’ immature red cells. Caution should be exercised while breast feeding an infant known or suspected to have an

erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

Side effect: Respiratory: If any of the following reactions occur the drug should be discontinued. Acute pulmonary reactions,

subacute reactions may take several months to resolve once the drug has been stopped. Chronic pulmonary reactions occur rarely in

patients who have received continuous therapy for 6 months or longer and are more common in elderly patients. Changes in ECG have

occurred, associated with pulmonary reactions. Minor symptoms such as fever, chills, cough and dyspnoea may be significant.

Hepatic: Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely. Treatment should be stopped

at the first sign of hepatotoxicity. Neurological: Peripheral neuropathy (including optical neuritis) with symptoms of sensory as

well as motor involvement, which may become severe or irreversible, has been reported infrequently. Treatment should be stopped at

the first sign of neurological involvement. Gastrointestinal: Nausea and anorexia have been reported. Haematological:

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia and megaloblastic anaemia, glucose-6-phosphate

dehydrogenase deficiency anaemia, and eosinophilia have been reported. Cessation of therapy has generally returned the blood

picture to normal.

Drug interactions:

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and

    sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and

    urine alkalization.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine.

Overdose: Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote.

However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by

gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake

should be maintained to promote urinary excretion of the drug.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Umactin-50 capsule: Cartons containing 30 capsules in blister.

Umactin-100 capsule: Cartons containing 30 capsules in blister.

Umactin-BD 100 capsule: Cartons containing 14 capsules in blister.

Umactin oral suspension: Glass bottle containing 100ml suspension.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

Gazipur, Bangladesh

® Registered Trademark