DOSAGE
AND ADMINISTRATION
One applicator full of Clotrimazole should be inserted deep into the
Vagina preferably at bedtime for seven consecutive days.
Direction of use of the Applicator:
1.
Remove the cap from the tube and attach the applicator in its place.
2. Squeeze the tube from the bottom to fill the
Gel into the cylinder and push out the plunger as far out till the cylinder
is filled.
3. Always roll the tube from the bottom to allow
easy filling of the Applicator and complete utilization of the contents.
4. Remove the filled Applicator from the tube
with the cap.
5.
Hold the filled
Applicator by the cylinder and gently insert the Applicator into the vagina
as deeply as possible. Press the plunger completely to empty the contents
of the Applicator. With the plunger still depressed, remove the applicator
from the vagina, holding it by the cylinder.
Insertion can be carried out more easily when lying on the back with the knees
bent and spread out.
6. The Applicator after each use should be taken
apart for cleaning by holding the cylinder with one hand and pulling out the
plunger with single force. Wash with soap and lukewarm water (not boiling
water). Rinse thoroughly. To reassemble the Applicator, insert the plunger
into the cylinder
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Clotrimazole is indicated in Vaginal candidiasis. Vaginal Trichomoniasis, mixed Vaginal infections, Bacterial vaginitis, and infective leucorrhoea.
(iii) DESCRIPTION OF DOSAGE FORM
Clotrimazole
is a new synthetic antifungal drug belonging to imidazole group. Its chemical
formula is C22H17CIN2.
Spcetrum of Action
Clotrimazole is a broad spectrum antifungal agent that offers efficient treatment
for all vagial infections caused by candida species. Trichomonas vaginalis
and certain gram positive and gram negative bacteria.
(iv) CONTRAINDICATIONS
Contraindicated in patients with known hypersensitivity to the product.
WARNINGS AND PRECAUTIONS
Contact
your doctor if you experience increased skin irritations (such as redness,
itching, burning, blistering, swelling, or oozing).
Check with your doctor before using this medication on a child.
In general, if your symptoms have not improved within 2 to 4 weeks of treatment,
notify your doctor.
Clotrimazole vaginal preparations should not be used if you have abdominal
pain, fever, or a foul-smelling vaginal discharge. Contact your doctor immediately.
While using the vaginal preparations, either avoid sexual intercourse or make
sure your partner uses a condom. This will prevent re-infection. Oils used
in some vaginal preparations can weaken latex condoms or diaphragms. To find
out whether you can use your medication with latex products, check with your
pharmacist.
Clotrimazole Vaginal Cream may reduce the effectiveness and safety of latex
products, such as condoms and diaphragms. This effect is temporary and occurs
only during treatment.
USE
DURING PREGNANCY
The use of clotrimazole during the first trimester of pregnancy has not been
adequately studied. It should be used during the first trimester only if clearly
needed. Do not use clotrimazole at any time during pregnancy without the advice
and supervision of your doctor.
It is not known whether clotrimazole appears in breast milk. Nursing mothers
should use this medication cautiously and only when clearly needed.
INTERACTION
None have been reported.
(v)
SIDE EFFECTS
Abdominal/ stomach cramps/pain, burning/ irritation of penis of sexual partner,
headache, pain during sexual intercourse, skin rash, hives, vaginal burning,
vaginal irritation, vaginal itching, vaginal soreness during sexual intercourse.
(vi) TOXIC EFFECTS
TERATOGENICITY, MUTAGENICITY AND CARCINOGENICITY
An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect. No teratogenicity or mutagenicity has been observed in animal studies. Studies in human given intravaginal clotrimazole during the second and third trimesters have not shown that clotrimazole causes adverse effects on the fetus.
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Richmond Hill, Ont.
Canada, L4B 3B2