HAGINIR 100

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COMPOSITION:

Cefdinir.....................................................100 mg

Excipients q.s........................................ 1 capsule

(Aerosil, avicel M112, talc, magnesium stearate).

DOSAGE FORM: Hard capsule.

PRESENTATION: Box of 3 blisters x 10 capsules.

PHARMACODYNAMICS:

Haginir contains the active ingredient cefdinir which is classified as a third generation cephalosporin and has an extended spectrum of activity against gram-positive and gram-negative bacteria. Bactericidal property of cefdinir results from inhibition of bacterial cell wall synthesis. Cefdinir is not affected by the beta-lactamase enzymes. Particularly, cefdinir has been shown to be active against gram-positive bacteria e.g. Staphylococcus sp., Streptococcus sp. resistant to other previously oral cephalosporins. Cefdinir is inactive against Enterococci (Enterococcus faecalis) and methicillin-resistant Staphylococci.

PHARMACOKINETICS:

Cefdinir is widely distributed into body tissues and fluids. Cefdinir is metabolized in the liver and is mainly excreted via the kidneys. Elimination half-life of cefdinir is 1.7 hours. Estimated bioavailability of cefdinir is 21% following administration of a 300 mg dose, 16% following administration of a 600 mg dose.

INDICATIONS:

Community-acquired pneumonia, acute course of chronic bronchitis, acute bronchitis, pharyngitis, tonsillitis.

Folliculitis, paronychia, impetigo, hypodermic abscesses, vasculitis or lymphadenitis.

Pyelonephritis, cystitis, and netritis.

CONTRAINDICATIONS:

Hypersensitivity to any ingredients of the drug or the cephalosporin class of antibiotics.

PRECAUTIONS:

Allergic to penicillin or other drugs.

A history of colitis.

There have been reports of reddish tools in patients given cefdinir with iron supplement concomitantly.

Children aged less than 6 months.

PREGNANCY AND LACTATION:

Cefdinir should be used with caution during pregnancy and lactation.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

The drug should be used with cautions in drivers and machine users.

INTERACTIONS:

Cefdinir should be taken at least 2 hours before or after the antacid or iron supplements by reduction of bioavailability.

Probenecid inhibits the renal excretion of cefdinir.  

ADVERSE EFFECTS:

Rarely: Nausea, vomiting, colic, anorexia, constipation, headache, dizziness, stomatitis, fungal infection, deficiency of vitamin K and the B-group vitamins, leukopenia, increase in hepatic enzyme levels, increase in blood urea nitrogen (BUN).

Please inform your doctor of all undesirable effects upon drug administration.

OVERDOSAGE:
Symptoms following overdosage with cefdinir have included nausea, vomiting, epigastralgia.

Symptomatic treatment is mainly applied. The drug should be removed from the body. Hemodialysis removes cefdinir from the body.

DOSAGE & ADMINISTRATION:

Oral route. Treatment duration is from 5 to 10 days.

Adults and children aged more than 12 years: 600 mg/day given once or in 2 divided doses every 12 hours. For patients with renal impairment (CrCl < 30 ml/min): 300 mg once daily. 

Children aged from 6 months to 12 years: The usual dose is 14 mg/kg of body-weight/day, given once or in 2 divided doses every 12 hours (maximum dose of 600 mg/day). Patients with renal impairment (CrCl < 30 ml/min): 7 mg/kg of body-weight/day.

Or as directed by a physician.

Read the direction carefully before use.

For more information, please consult a physician.

The drug is for prescription only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 300C, protect from light.

Specifications: Manufacturer’s

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