Source: Registered Drug Product Database (NG) Publisher: Registrant: ANTILA LIFESCIENCE PVT.LTD., 817, 8 th Floor Devpath, B/H Lal Bunglow, Off. C.G.ROAD, Ahmedabad, Gujarat, India Manufacturer: ANTILA LIFESCIENCE PVT.LTD., MFG. AT: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
The recommended dose of Co-Strimax is one capsule (0.5 mg/0.4 mg) once daily.
Where appropriate, Co-Strimax may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment.
Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Co-Strimax may be considered.
The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.
The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of Co- Strimax is contraindicated.
Dutasteride-tamsulosin is contraindicated in the paediatric population (under 18 years of age).
For oral use.
Patients should be instructed to swallow the capsules whole, approximately 30 minutes after the same meal each day. The capsules should not be chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa.
No data are available with regard to overdosage of Co- Strimax. The following statements reflect the information available on the individual components.
In volunteer studies, single daily doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for dutasteride, therefore, in suspected overdosage symptomatic and supportive treatment should be given as appropriate.
Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
36 months from the date of manufacturing.
Protect from light & moisture. Store below 30°C. Keep medicine out of reach of children.
CO-STRIMAX is packed in 3 X 10 Capsules Alu-Alu blister pack in a printed carton along with package insert.
No special requirements.
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