Amikap Ampicillin Capsules

AMIKAP CAPSULES

Ampicillin Capsules BP 250 mg

For use of a Registered Medical Practitioner or a Hospital or a Laboratory.
 

Composition

Each capsule contains

Ampicillin Trihydrate BP

Equivalent to Ampicillin 250mg

Excipients q.s.

 

Description

Ampicillin is semi-synthetic Penicillin, a broad spectrum antibiotic effective against a wide range of Gram-positive and Gram-negative organisms. It is stable in the presence of gastric acid and is well absorbed from G.I.T. Ampicillin is excreted largely unchanged in the urine and is inactivated by Penicillinase producing organisms.

 

Clinical Pharmacology

Ampicillin is bactericidal at low concentrations and is clinically effective not only against the gram-positive organisms usually susceptible to penicillin G but also against a variety of gram-negative organisms. It is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract. It diffuses readily into most body tissues and fluids; however, penetration into the cerebrospinal fluid and brain occurs only with meningeal inflammation. Ampicillin is excreted largely unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid which inhibits the renal tubular secretion of ampicillin in blood serum, ampicillin is the least bound of all the penicillins, an average of about 20 percent of the drug is bound to the plasma proteins as compared to 60 to 90 percent of the other penicillin’s. The average peak serum level for a 250 mg dose of ampicillin trihydrate for oral suspension is approximatety 2.3 mcg/mL.

 

Indication and Usage

Ampicillin is part of a group of antibiotics called penicillin and is used to treat different types of infections caused by bacteria such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or Salmonella infections.

 

CONTRAINDICATIONS

A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication. Ampicillin is also contraindicated in infections caused by penicillinase-producing organisms.

 

Drug Interactions

When administered concurrently, the following drugs may interact with ampicillin.

Allopurinol: Increased possibility of skin rash, particularly in hyperuricemic patients may occur.

Bacteriostatic Antibiotics: Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in view, however, the clinical significance of this interaction is not well documented.

Oral Contraceptives: May be less effective and increased breakthrough bleeding may occur.

Probenecid: May decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.

 

Warnings

Caution should be exercised in patients with history of kidney or liver disease, any allergy, asthma, blood disease, intestinal inflammation, stomach problems, hay fever, who are taking other medications, children, during pregnancy and breastfeeding.

* It may cause dizziness, do not drive a car or operate machinery while taking this medication.

* Take full course of treatment.

*Avoid long-term use of this medication; otherwise it may cause secondary infection.

* Patient may experience stomach pain, severe diarrhoea, blood in stool; if it’s so consult with your doctor.

 

Use in pregnancy

Teratogenic effects: Category B

Reproduction studies in animals have revealed no evidence of impaired fertility or harm to the fetus due to penicillin. There are, however no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed.

 

Nursing Mothers

Ampicillin-class antibiotics are excreted in milk. Ampicillin used by nursing mothers may lead to sensitization of infants; therefore, a decision should be made whether to discontinue nursing or to discontinue ampicillin, taking into account the importance of the drug to the mother.

 

Precautions

Do not take Ampicillin Capsules if you allergic to penicillin, Ampicillin or any other drug. You should tell your health care provider if you are taking any other prescribed or over the counter drugs (especially antibiotics) like allopurinol, anticoagulants such as (warfarin and atenolol) oral contraceptives, probenecid, rifampin, sulfasalaszine and vitamins.

Tell your health care provider if you have or have had any kidney or liver diseases, allergies, asthma, blood disease; colitis, stomach problems or hay fever.

If you plan on having surgery (including dental) always inform your health care provider that you are taking Ampicillin Capsules. If you are pregnant or plan on becoming pregnant, discuss your options with your health care provider or pharmacist.

 

Side Effects

Some of the common side effects include nausea, mild diarrhoea, loss of appettite, vomiting, confusion, dizziness and mild skin rash. Inform your health care provider if any of the above side effects become bothersome. Consult with your health care provider immediately if any of the following  more severe side effects are experienced: severe skin rash, itching, hives, difficulty breathing or swallowing, wheezing and vaginal infection.

 

Over dosage and Antidote

Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include confusion, behaviour changes, a severe skin rash, urinating less than usual, or seizure (black-out or convulsions).

In case of over dosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodalysis but not by peritoneal dialysis

 

Dosage and Administration

As directed by the physician, Adults, Elderly and Children over 10 years old: The usual dose is 250 mg three times a day. For severe infections your doctor may increase your dose to 500 mg three times a day. Children under 10 years old: For severe infections your doctor may give your child 250 mg three times a day.

 

Storage

Store below 25oC and dry place, protect from light. Keep out of reach of children.

 

Presentation

Carton of 10 blisters of 10 capsules each.

 

Marketed by

Maydon Pharmaceuticals Ltd.

15, Wilmer Street, Off Town Planning Way,

Ilupeju, Lagos-Nigeria.

 

Manufactured in India by

Maxheal Pharmaceuticals (India) Ltd.

H.Q.: Maxheal House, Goregaon-W, Mumbai-090

Factory: 956, M.I.D.C., Satpur, Nashik-422 007

www.maxheal.in