Azithrophin Azithromycin Capsules

AZITHROPHIN CAPSULES (AZITHROMYCIN 500MG)

Description, Clinical data, Indications, Contraindications, Adverse reaction, Precautions, Dosage and administration, Overdosage, Presentation, Marketing authorisation numbers and Manufacturer of Azithrophin Capsules Medicine for Infections and Typhoid fever.

 

Description

AZITHROPHIN has the chemical name (2R,3S,4R,5R,8R, 10R, 11R, 12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4, 10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]-1-oxa-6-azacycyclopentadecan-15-one.

Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00.

Each capsule contains:

Azithromycin Dihydrate U.S.P.

Equivalent to Azithromycin 500mg

 

Clinical Data

Following oral administration, azithromycin is rapidly absorbed and widely distributed throughout the body. Rapid distribution of azithromycin into tissues and high concentration within cells result in significantly higher azithromycin concentrations in tissues than in plasma or serum.

Biliaiy excretion of azithromycin, predominantly as unchanged drug, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

There are no pharmacokinetic data available from studies in hepatically-or renally-impaired individuals. The effect of azithromycin on the plasma levels or pharmacokinetics of theophylline administered in multiple doses adequate to reach therapeutic steady—state plasma levels is not known.

 

Indications

In the treatment and prophylaxis of susceptible infections including Mycobacterium avium Complex (MAC) infection; prophylaxis in treatment ofendocarditis in high riskPenicillin-Allergic patient.

In treatment uncomplicated urinary tract infection due to Chlamydia trichomatis and N. gonorrhea.

Upper and lower respiratory tract infections.

Skin and soft tissue infections

In the treatment of Multi-Drug resistant typhoid fever.

 

Contra-Indications

Hypersensitivity to the drug orother macrolides

 

Adverse Reaction

Mild to moderate nausea, vomiting, abdominal pains, dyspepsia, flatulence, diarrhea, cramping, angiodema, cholestattic jaundice, headache, dizziness, vertigo, transient elevation of liver enzymes values.

 

Precautions

Dose adjustment may be necessary in patients with impaired renal and, or liver function. Co-administration with Ergot containing products or derivatives should be avoided to prevent occurrence of Ergotism (as applicable to other macrolides).

 

Dosage and administration

In most indicated infections other than Typhoid fever a daily dose of 10mg/kg/day or one capsule daily for 3-5days is recommended.

In typhoid fever: 20mg or 0.5ml/kg/day (maximum dose 1000 mg/day) for 5 days and 10mg or 0.25m1/kg/day (maximum dose 500 mg/day) for 7 days have been used successfully in the treatment of typhoid fever in pediatric and adult patients accordingly (Frenck et al, 2004; Frenck et al, 2000).

 

Overdosage

Gastric lavage and general supportive measures are indicated.

 

Presentation

azithrophin capsule contains 500mg Azithromycin packed in a light protected Alu-Alu blister of 6’s.

 

MARKETING AUTHORISATION NUMBER(S)

G/28/1330

Artwork No. :5330102-00

 

Manufactured for

FRANPHINO PHARM. CO. LTD,

44, Mosalashi Street, Mushin, Lagos, Nigeria

 

Manufactured by

Saga LABORATORIES

Plot No. 1409, Phase III, G.I.D.C. Estate,

Vatwa, Ahmedabad-382 445, India.