SHREE CEDRINE
(Proguanil Tablets BP 100 mg)
For the use of Registered medical Practitioner or a Hospital or a Laboratory.
COMPOSITION
Each Uncoated Tablet Contains:
Proguanil Hydrochloride BP 100mg
MECHANISM OF ACTION
The active triazine metabolite, inhibits plasmodial dihydrofolate reductase and thus disrupts the synthesis of nucleic acids in the parasite.
INDICATIONS
Shree Cedrine is indicated for the Causal prophylaxis of falciparum (P. falciparum) malaria; proguanil also suppresses other forms of malaria, and it is used to reduce transmission of infection. Proguanil should not be used alone in countries where chloroquine-resistant malaria has been confirmed.
CONTRAINDICATIONS
Known or suspected hypersensitivity to proguanil.
DOSAGE AND ADMINISTRATION
For prophylaxis of malaria
Adults
Usual dose is 100 mg daily. In highly endemic areas this dose may be safely increased to 200 mg daily. The daily dose is best taken with water after food.
Non-immune subjects entering malarious region are advised to begin treatment with proguanil at least 24 hours before arrival. A daily dose of proguanil should be continued for 6 weeks after leaving the area.
Elderly
There are no special dosage recommndations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.
Children
Under 1 Year: 25 mg daily; 1 to 4 years: 50 mg daily; 5 to 8 Years: 75 mg daily; 9 to 12 Years: 100 mg daily; Over 12 Years: adult dose daily.
For a young child, the dose may be administered crushed and mixed with milk, honey or jam.
For all countries with chloroquine-resistant malaria: The dose of proguanil is increased to 200 mg daily with chloroquine (base) given 300 mg once a week, i.e. approximately equivalent to 500 mg chloroquine phosphate.
OVERDOSE
For more information on the management of overdose or unintentional ingestion contact a Poison Control Center (see Poison Control center Listing).
Clinical effects of overdose
The following effect have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)-not necessarily inclusive:
Acute
Epigastric discomfort (abdominal or stomach pain) hematuria (blood in urine; lower back pain; pain or burning while urinating); renal irritation (pain or burning while urinating); or vomiting.
Treatment of overdose
Because there is no specific antidote for proguanil overdose, treatment should include the following:
Specific treatment-symptomatic treatment may be given.
Supportive care-supportive measures necessary for maintaining the vital functionsd of the patient may be administered. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
ADVERSE EFFECTS
At normal therapeutic doses, the adverse effect most commonly encountered is mild gastric intolerance. This usually subsides as treatment is continued. Mouth ulceration has occasionally been reported. Large doses (1 g daily) may cause vomiting, abdominal pain, hematuria and renal irritation. Blood dyscrasias have been reported in patients with renal failure given proguanil.
Selected cases of skin reactions and reversible hair loss have been reported in association with the use of proguanil.
PRECAUTIONS
It is generally accepted that all drug treatment should be avoided if possible during the first trimester of pregnancy. A casual connection between the use of proguanil and any adverse effect on mother and fetus has never been established, but the attending physician should carefully weigh the expected benefits against the potential risks.
Use proguanil with caution in patients with severe renal impairment.
SPECIAL PRECAUTIONS
Renal impairment, Mouth ulcers with renal impairment, other mediactions. Reduced dose necessary in children. The drug passes into breastmilk. Safety in pregnancy not established, although benefits generally considered to outweigh risks. Folate supplements indicated.
DRUG INTERACTIONS
Fluvoxamine: Fluvoxamine can virtually abolish the metabolism of proguanil to its active metabolite cycloguanil via an inhibitory effect on the cytochrome P450 isoenzyme CYP2C19.
Warfarin: For a report of haematuria and high prothrobin ratio in a patient stabilized on warfarin who took proguanil for malaria prophylaxis.
STORAGE CONDITIONS
Store in a cool place and protect from light.
Keep all medicines out of reach of children.
PRESENTATION
Jar pack of 100 tablets.
Mfg. Lic. No.: KD-493
Nafdac Reg. No.: 04-9113
Manufactured by
Pharmaceuticals Pvt. Ltd.
Plot No. 59, 60, 85, 86, V.M.I.E.,
Dowall Village, Vasal (W),
Dist. Thane, Maharashtra, India.
Sole Agent
Shree Aloe Pharmaceuticals Co., Nig., Ltd.
3, Balewa Street, Fegge, Onitsha,
Anambra State, Nigeria.
