2. Pramoxine and zinc oxide topical (for the skin) is a combination medicine
used to temporarily relieve pain, itching, burning, irritation, or soreness
caused by hemorrhoids.
3. MECHANISM OF ACTION
Pramoxine: local anesthetic due to inhibition of conduction of nerve
impulses from sensory nerves, resulting from an alteration of the cell
membrane permeability.
Zinc oxide: antiseptic and protectant properties.
Absorption – minimal
Onset: 3-5 min
4. DOSAGE & INDICTIONS
PEDIATRICS
DOSAGE FORMS & STRENGTHS
Pramoxine/mineral oil/ zinc oxide rectal
TOPICAL OINTMENT
1%/ 46.6%/ 12.5%
TOPICAL PAIN
For symptomatic relief of the discomfort associated with hemorrhoids, perianal
itching or irritation.
<12 years: safety and efficacy not established
≥12 years: apply externally to affected area up to 5 times daily PRN
5. ADULTS
Topical ointment
1%/ 46.6%/ 12.5%
TOPICAL PAIN
For symptomatic relief of the discomfort associated with hemorrhoids, perianal itching, or
irritation.
Apply externally to affected area up to 5 times daily PRN
6. INTERACTIONS
Beta carotene;
.mineral oil decreases levels of beta carotene by drug binding in GI tract.
Use caution/ monitor.
Vitamin D
.mineral oil will decrease the level or effect of vitamin D. Use caution/
monitor. Avoid concomitant use of mineral oil and vitamin D supplements to
avoid risks of decreased absorption of vitamin D. Applies to only oral
administration of these agents.
8. WARNINGS
Contraindications
Hypersensitivity
Cautions
For external use only
Do not use in the eyes
Do not use on blistered or broken skin
If conditions worsen, or if symptoms persist for >7days or clear up and
occur again within a few days, discontinue and reassess therapy.
9. PREGNANCY
Pregnancy category: Undetermined, use with caution.
Lactation: Unknown if excreted in breast milk, caution advised.
Pregnant or breastfeeding patients should seek advice of health
professional before using OTP drugs.
10. hydrocortisone
It suppresses the normal immune response and inflammation, i.e,
suppresses dermatological inflammation and immune
11. PHARMACOKINETICS.
Minimal absorption but its prolonged use increases its systemic
absorption. It primarily remains at the site of absorption, metabolized in
the skin, and plasma half life of 1.5 to 2 hrs.
Time and action depends on the condition being treated.
12. INDICATIONS
Inflammation.
Pruritis
DOSAGE
Aerosal form going for 1 to 2 times a day for two to three weeks then
adjusted.
AVAILABILITY
Rectal cream1% and rectal aerosol 10%.