No Gravida Vaginal Suppositories

Composition:
Each 2 gm vaginal suppository contains:
Active Ingredient:
Nonoxynol-9 100 mg
Inactive Ingredients:
Cetomacrogol 1000, Povidone k29-32, Citric acid anhydrous, Sodium bicarbonate, PEG 1000,
PEG 4000.

PHARMACEUTICAL FORM:
Vagina Suppositories

CLINICAL PARTICULARS
Therapeutic indications
For use as a spermicidal contraceptive in conjunction with barrier methods of Contraception such as
diaphragms or caps.

Posology and method of administration

Method of Administration
For vaginal use.
For use by adult females only.
Posology
In order to prevent pregnancy.
At least 10 minutes prior to intercourse: Remove the protective wrap and insert No Gravida into
the vagina. Each No Gravida Vaginal suppository gives you one full hour of protection.
May be used with: condom or diaphragm for added protection.

Douching is not recommended, but if desired it should be deferred for at least six hours after
intercourse.

Contraindications
Hypersensitivity to nonoxinol-9 or to any component of the preparation.
Patients with absent vaginal sensation e.g., paraplegics and quadriplegics.

Special warnings and special precautions for use

Spermicidal intravaginal preparations are intended for use in conjunction with barrier methods of
contraception such as diaphragms and caps. No Gravida is not required for use with condoms as
there is no evidence of any additional protection against pregnancy.
Where avoidance of pregnancy is important, the choice of contraceptive method should be made
in consultation with a doctor or a family planning clinic.
This product does not protect against HIV (AIDS) or other sexually transmitted diseases (STDs).
A latex condom should be used to protect against the spread of STDs. High frequency use of
nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection.
Therefore women at risk of HIV/STD infection and who have multiple daily acts of intercourse
should be advised to choose another method of contraception. Sexually active women should
consider their individual HIV/STD infection risk when choosing a method of contraception.
If vaginal or penile irritation occurs, discontinue use. If symptoms worsen or continue for more
than 48 hours, medical advice should be sought.

A diaphragm should not be left in the vagina for longer than 24 hours.

Interactions with other medicaments and other forms of interaction

Some vaginal products and lubricating agents may contain ingredients that can damage
contraceptive diaphragms/caps made from latex rubber. As a result these may be less effective as
a barrier against pregnancy and as a protection from sexually transmitted diseases including HIV.
The following products should NOT be used at the same time as a vaginal diaphragm
or cap:
• Petroleum jelly (Vaseline);
• Mineral oil (baby oil);
• Oil-based vaginal and rectal preparations.

Pregnancy and lactation

There is no evidence from animal and human studies that nonoxinol-9 is teratogenic. Human
epidemiological studies have not shown any firm evidence of adverse effects on the foetus,
however some studies have shown that nonoxinol-9 may be embryotoxic in animals. This
product should not be used if pregnancy is suspected or confirmed. Animal studies have detected
nonoxinol-9 in milk after intravaginal administration. Use by lactating women has not been
studied.

Effects on ability to drive and use machines

None known.

CLINICAL PARTICULARS
Undesirable effects
Nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection.
It may cause hypersensitivity and application site reactions such as irritation, pain, discomfort,
burning sensation, itching, dryness, rash and redness of the vulva, vagina or penis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via
pv.report@edaegypt.gov.eg.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
The standard in vitro test (Sander-Cramer) evaluating the effect of nonoxinol-9 on animal sperm
motility has shown the compound to be a potent spermicide.
The site of action of nonoxinol-9 has been determined as the sperm cell membrane. The
lipoprotein membrane is disrupted, increasing permeability, with subsequent loss of cell
components and decreased motility. A similar effect on vaginal epithelial and bacterial cells is
also found.
Pharmacokinetic properties
The intravaginal absorption and excretion of radiolabelled (14C) nonoxinol-9 has been studied in
non-pregnant rats and rabbits and in pregnant rats. No appreciable difference was found in the
extent or rate of absorption in pregnant and non-pregnant animals. Plasma levels peaked at about
one hour and recovery from urine as unchanged nonoxinol-9 accounted for approximately 15
25% and faeces approximately 70% of the administered dose as unchanged nonoxinol-9. Less
than 0.3% was found in the milk of lactating rats. No metabolites were detected in any of the
samples analysed.

Special precautions for disposal

Not applicable.

Incompatibilities
Not applicable.

Storage conditions:
Store at temperature not exceeding 2-8° C.

Pack:
Carton box containing 2 opaque PVC white strips, each of 6 vaginal suppositories and an inner
leaflet.

Shelf life: 2 Years.

Manufactured by:
South Egypt Drug Industries Company (SEDICO).
For: DKT