ANAMOL

COMPOSITION
ANAMOL 80 MG
Each suppository contains:
PARACETAMOL - 80mg

ANAMOL 170 MG
Each suppository contains:
PARACETAMOL - 170 mg

ANAMOL 250 MG
Each suppository contains:
PARACETAMOL - 250 mg

DESCRIPTION
Fever in children is one of the most frequent and debilitating conditions. Oral
medications are available; however, a rectal suppository is a better alternative,
specially in convalescent children. Studies have evaluated this system to be
effective, equivalent and safe in comparison to the oral route. It also gives
prolonged duration of action and has improved patient compliance.

Paracetamol, a commonly used and generally regarded as safe drug has been
formulated in the rectal delivery form. It exerts equivalent action with lower risk
of hepatotoxicity, which is a risk factor in the oral route.

HIGHLIGHTS (USPs)
· Rapid decline in elevated body temperature
· Reliable in treating febrile convulsions
· Prolonged duration of action -- Time to ‘rescue’ analgesic with Anamol
suppositories was 7hrs compared to 4hrs with Paracetamol IM
· Less hepatotoxicity as compared to oral formulations as it avoids hepatic
first pass metabolism
· Has been formulated using PEG base, the most stable and accepted base
· Ideal for nauseating, vomiting, fussy & non-cooperative children
· No need of refrigeration

CATEGORY
Analgesic & antipyretic.

CLINICAL PHARMACOLOGY
Paracetamol is a peripherally acting analgesic and is well absorbed orally.
Paracetamol produces analgesia by elevation of the pain threshold and
antipyresis through action on the hypothalamic heat-regulating center.
Paracetamol is equal to aspirin in analgesic and antipyretic effectiveness.

The plasma elimination half-life ranges from 1 - 4 hours for paracetamol.

Paracetamol is distributed throughout most fluids of the body, and is
metabolized primarily in the liver. Little unchanged drug is excreted in the urine,
but most metabolic products appear in the urine within 24 hours.

INDICATIONS AND USAGE

§ Analgesia in children
§ Symptomatic relief of pain and fever of pediatric patients associated with:
o Teething
o Immunization
o Cold & Flu
o Earache
o Headache

CONTRAINDICATIONS
Any inflammatory lesions of rectum or anus.
Recent history of rectal or anal bleeding.
PRECAUTIONS
Do not use in case of open wounds and bleeding.

ADVERSE REACTIONS
ANAMOL is generally well tolerated; however, transient reactions such
reddening of the skin may occur, albeit rarely; allergic reactions with cutaneous
eruption are rare.

DOSAGE AND ADMINISTRATION

Initial Dosage
Dosage of paracetamol is governed by age and body weight, and is usually 10-
15mg paracetamol per kg body weight as a single dose, and up to 60mg/kg
body weight as a maximum dose per day (24 hours).

Anamol-80: Up to 7 kg (about 6 months old): 1 suppository of 80 mg, to take

twice if needed, after 6 hours, without taking more than 4 suppositories per day.

Anamol-170: Up to 12-16 kg (about 2-4 years old): 1 suppository of 170 mg, to

take twice if needed, after 6 hours, without taking more than 4 suppositories per
day.

Anamol-250: Up to 17-22 kg (about 4-7 years old): 1 suppository of 250 mg, to

take twice if needed, after 6 hours, without taking more than 4 suppositories per
day.

How to use suppositories

1. Administer suppository, preferably after passing stools.
2. Wash your hands before using suppository.
3. Keep the area of insertion (rectum) clean.
4. Detach one suppository from the strip.
5. Do not break the suppository.
6. Remove wrapper from suppository by holding suppository upright
and carefully peeling wrapper evenly down both sides of suppository
7. Avoid excessive handling.
8. Suppository should not be taken by mouth.
9. Moisten the Suppository, before use.
10. Position the patient flat on back or on one side, with anal opening
exposed.
11. Gently insert the suppository, pointed end first, well into the rectum.
12. Use index fingertip for complete insertion.
13. If necessary, hold buttock together for 30-60 seconds to keep
suppository in place.
14. After inserting wash your hands thoroughly.

PRESENTATION
ANAMOL Suppositories: 1 strip of 5’s for Rs. 20/-