Ovide

• Malathion is used for treating people who have head lice and their eggs (Pediculus humanus capitis).

OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of malathion is (±) - [(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C10H19O6PS2, and has the following chemical structure:

Consideratio n should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.

Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentall y swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning re quiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.

Repeat analyses o f serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - ra nge prognosis.

1. OVIDE Lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. The person applying OVIDE Lotion should wash h ands after application. Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion.
2. OVIDE Lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.
3. In case of accidental ingestion of OVIDE Lotion by mouth, seek medical attention immediately.
4. If you are pregnant or nursing, you should contact your physician before using OVIDE Lotion.
5. If OVIDE Lotion comes into contact with the eyes, fl ush immediately with water. Consult a physician if eye irritation persists or if visual changes occur.
6. If skin irritation occurs, wash scalp and hair immediately. If th e irritation clears, OVIDE Lotion may be reapplied. If irritation reoccurs, consult a physician.
7. Burns and stinging sensations may occur when using OVIDE Lotion.
8. Apply OVIDE Lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying OVIDE Lotion. Anyone applying OVIDE Lotion should wash hands immediately after the application process is complete.
9. Allow hair to dry naturally and to remain uncovere d. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing.
10. Rinse hair and use a fine - toothed (nit) comb to remove dead lice and eggs.
11. If lice are still present after 7 - 9 days, repeat with a second application of OVIDE Lotion.
12. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Do not use other medicated skin products unless your doctor has told you to.

Avoid sexual or intimate contact with others until your lice or scabies infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. Lice and scabies infections are highly contagious.

Ovide is a prescription medication used to treat head lice (Pediculus humanus capitis) in adults and children 6 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before receiving this medication, tell your doctor about all of your medical conditions including if you:

• are allergic to any ingredient in Ovide lotion
• have severe skin sensitivities
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take Ovide exactly as prescribed.

Ovide comes as a lotion that is applied to the scalp and hair.

One treatment may be effective, but sometimes a second Ovide treatment is required. If live lice are seen 7 to 9 days after the first treatment then a second application is necessary.

This lotion should only be applied to hair and scalp. If skin irritation occurs, wash scalp and hair right away. If the irritation does not persist, you can apply Ovide Lotion again. If skin irritation occurs again, contact your doctor.

To use Ovide lotion, follow these steps:

1. Be sure to keep your eyes closed during this treatment. 

2. Apply Ovide lotion to dry hair and scalp area paying special attention to area behind your ears and at the back of your neck. Use enough lotion to thoroughly cover hair and the entire scalp area.

3. Allow hair to air dry. Keep hair uncovered.

4. Leave the lotion on your hair and scalp for 8 to 12 hours.

5. After 8 to 12 hours have passed, shampoo your hair and scalp with warm water in a sink. Using the sink is best, instead of a shower or bathtub, because you do not want to get the lotion over the rest of your body.

6. It is important to wash your hands after the application and rinsing steps.

7. Use a lice comb to remove the dead lice and nits (empty egg shells) after this treatment. 

8. If you see live lice on your head 7 to 9 days after treatment, repeat this entire process.

After using Ovide lotion, sanitize all the clothing, underwear, pajamas, hats, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned. You should also wash combs, brushes, hairs clips and other personal care items in hot water.

General

Measures to Avoid Reinfestation and Transmission

• To avoid reinfestation or transmission of pediculosis, most experts recommend that clothing and bed linen that may have been contaminated by the infested individual during the 2 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer, dry-cleaned, or treated with an appropriate pesticide) or removed from body contact for ≥72 hours.69 66 79 81

• Items that cannot be laundered or dry-cleaned should be removed from contact and sealed in a plastic bag for 10–14 days.56 61 66 79 81

• Combs and brushes used by the infected patient may be disinfected by soaking in hot water (temperature >54°C) for 5–10 minutes;4 56 61 66 81 alternatively, they can be soaked in alcohol or a pediculicide for 1 hour.4 6 21 81

• Furniture and floors of rooms inhabited by patients infested with lice should be thoroughly vacuumed.56 61 65 66 79 81 Fumigation of living areas is not necessary and is not recommended.69 77 79 81

• In the treatment of pediculosis capitis (head lice infestation), a fine-toothed comb often is recommended to remove any remaining nits (eggs) or nit shells.1 4 6 21 56 66 70 79 81 Some clinicians do not consider nit removal necessary since only live lice can be transmitted, but recommend it for aesthetic reasons and to decrease diagnostic confusion and unnecessary retreatment.54 61 79 Others strongly recommend removal of nits (especially those within 1 cm of the scalp) since no pediculicide is 100% ovicidal and potentially viable nits may remain on the hair after pediculicide treatment.33 70 72 79 Although many schools will not allow children with nits to attend, AAP and other experts consider these no-nit policies excessive.61 77 79

Administration

Topical Administration

Apply topically to scalp hair as a 0.5% lotion.1

For external use only.1 Do not apply topically to skin, eyes, or pubic area and do not administer orally.1

Avoid contact with the eyes.1 Eyes should be closed tightly and covered with a soft towel or washcloth while the lotion is applied to or washed off of scalp hair.1 If contact with the eyes occurs, immediately flush with water.1 If eye irritation persists or if visual changes occur, consult a clinician.1

Apply to dry hair; after application, leave hair uncovered and allow to dry naturally.1

Malathion 0.5% lotion is flammable.1 Do not expose the lotion or hair wetted with the lotion to an open flame, lighted cigarette, or electric heat source (e.g., hair dryer, electric curlers).1 Individuals applying the lotion or patients whose hair is wet with the lotion should refrain from smoking.1

Individuals applying malathion 0.5% lotion should wash their hands thoroughly after application is completed.1

Dosage

Pediatric Patients

Children ≥6 years of age: Apply to dry scalp hair in an amount sufficient to thoroughly wet the hair and scalp (including areas on the back of the head and nape of the neck).1 After 8–12 hours, wash hair (including areas on the back of the head and neck) with shampoo and rinse with water.1 Use a fine-tooth (nit) comb to remove dead lice and nits.1

One treatment usually is successful;70 treatment may be repeated after 7–10 days if live lice still are present.1 Additional treatments generally are unnecessary.1

Adults

Apply to dry scalp hair in an amount sufficient to thoroughly wet the hair and scalp (including areas on the back of the head and nape of the neck).1 After 8–12 hours, wash hair (including areas on the back of the head and neck) with shampoo and rinse with water.1 Use a fine-tooth (nit) comb to remove dead lice and nits.1

One treatment usually is successful;70 treatment may be repeated after 7–10 days if live lice still are present.1 Additional treatments generally are unnecessary.1

Contraindications

History of hypersensitivity to malathion or any ingredient in the formulation.1

Infants and neonates.1 (See Pediatric Use under Cautions.)

Warnings/Precautions

Warnings

Commercially available 0.5% lotion is flammable.1

Do not expose malathion 0.5% lotion or hair wet with the lotion to an open flame, lighted cigarette, or electric heat source (e.g., hair dryers, electric curlers).1 After application, leave the hair uncovered and allow to dry naturally.1

Individuals applying the lotion and those with hair wet with the lotion should refrain from smoking.1

Sensitivity Reactions

Potential for malathion 0.5% lotion to cause contact allergic sensitization unknown.1 Dermatitis of the scalp has been reported with topical malathion 5% lotion (10 times the usually recommended dosage).16 Contact dermatitis has been reported in individuals exposed to agricultural formulations of malathion.1 73

May be irritating to the skin and scalp;1 slight stinging sensation may occur after application of malathion 0.5% lotion.1 If skin irritation occurs, immediately remove the lotion by washing scalp and hair.1

After irritation clears, lotion may be reapplied.1 If irritation recurs, consult a clinician.1

General Precautions

Avoid contact with the eyes;1 mild conjunctivitis may occur.1 Do not use for treatment of pediculosis of the eyelashes.69

Eyes should be closed tightly and covered with a soft towel or washcloth while the lotion is applied to or washed off of scalp hair.1

If accidental contact with the eyes occurs, the affected eye(s) should be flushed thoroughly with water.1

Specific Populations

Category B.1

Not known whether malathion is distributed into human milk.1 Malathion was not detected in milk samples (minimum limits of detection <5 mcg/L) from nursing women who resided in geographic areas that received extensive aerial spraying with an agricultural formulation of malathion for insect control.48

Use caution when malathion 0.5% lotion is administered to or handled by a nursing woman.1

Safety and efficacy not established in children <6 years of age.1 Contraindicated in infants and neonates because their scalps are more permeable and increased absorption of malathion may occur.1

Keep out of reach of children; use on children only under the direct supervision of an adult.1

Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while their hair is wet with the lotion.1 (See Flammability under Cautions.)

Some clinicians recommend that the malathion preparation commercially available in the US not be used on small children or in children with asthma35 51 to prevent exposure to fumes from the isopropyl alcohol vehicle.35 51

Common Adverse Effects

Irritation of skin and scalp,1 stinging or burning.1 14 62 63 88

Absorption

Bioavailability

Systemic absorption of malathion following topical application of the 0.5% lotion commercially available in the US has not been specifically studied to date.1 87

Results of a study in healthy adults using several different aqueous- and alcohol-based formulations of topical malathion 0.5% (not the preparation commercially available in the US) indicate small amounts of the drug are absorbed following application to the scalp and the extent of absorption is similar between aqueous and alcoholic formulations.86

Malathion is absorbed systemically following ingestion,7 20 38 39 40 41 42 43 44 45 46 topical application to skin and mucous membranes,1 5 7 15 20 40 42 47 86 or inhalation of dusts or aerosols.7 20 42

Distribution

Extent

Not known whether malathion crosses the placenta following topical application.1

Not known whether malathion is distributed into milk following topical application.1 Not detected in milk samples (minimum limits of detection <5 mcg/L) from nursing women who resided in geographic areas that received extensive aerial spraying with an agricultural formulation of malathion for insect control.48

Elimination

Metabolism

Rapidly metabolized in vivo, principally by hydrolysis of the carboxyl ester linkage to inactive metabolites by carboxylesterases.7 11 15 20 23 37 44 49 62

Elimination Route

Malathion and its metabolites are excreted in urine;42 45 46 86 the monocarboxylic and dicarboxylic acid metabolites of malathion also are excreted in bile.45

In one study following topical application to the scalp of aqueous- or alcohol-based preparations of malathion (not the preparation commercially available in the US), approximately 0.2–3.2% of the applied malathion dose was eliminated in the urine as metabolites within 96 hours.86

• An organophosphate anticholinesterase insecticide used as a pediculicide.1 3 4 6

• Active in vitro and in vivo against Pediculus humanus var. capitis (head louse) and its nits (eggs)1 3 5 21 24 26 57 62 and Phthirus pubis (pubic or crab louse).24 Also active against Sarcoptes scabiei, the causative agent of scabies.25 30

• Therapeutic failure and resistance to malathion has been reported in P. humanus var. capitis34 35 62 75 83 and some strains of P. humanus var. corporis (body louse) in some areas of the world (e.g., United Kingdom, France, Israel).26 36 62 84 87 Clinical importance of these reports as it relates to treatment of lice infections in the US is unclear; prevalence of malathion resistance in the US has not been determined.77 87

• May be active against some P. capitis resistant to permethrin and pyrethrins.76 85

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Burning.
• Stinging.
• Very bad scalp irritation.
• Very bad skin irritation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Scalp irritation.
• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Rx Only

For topical use only. Not for oral or ophthalmic use.

Ovide® (malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5293-4.

Stored at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]

Flammable. Keep away from heat and open flame.

Manufactured for:
TaroPharma®
a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Mfd. By: Suven Life Sciences Limited, Plot No. 262-271, IDA, Pashamylaram, Medak District, Andhra Pradesh, 502307 India

Ovide® and TaroPharma® are trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

1b30005-4-00
Issued : September, 2013
0913-0