Oratane

Oratane uses

• Pharmacological action
• Pharmacokinetics
• Why is Oratane prescribed?
• Dosage and administration
• Oratane side effects, adverse reactions
• Oratane contraindications
• Using Oratane during pregnancy and lactation
• Special instructions
• Oratane drug interactions
• Oratane reviews

Pharmacological action

Oratane is a pharmaceutical agent for the treatment of acne. Contributes to the normalization of terminal cell differentiation, inhibits the hyperproliferation of the epithelium of excretory ducts of the sebaceous glands, the formation of detritus and makes it easier to evacuate. Due to this reduced production of sebum and facilitates its isolation, normal structure, decreasing the inflammatory reaction around the glands. For external and systemic application Oratane has antiseborrhea, sebostatic, anti-inflammatory, keratitis and immunomodulatory actions, strengthens the processes of regeneration in the skin.

Pharmacokinetics

When Oratane administered orally Oratane is absorbed from the gastrointestinal tract, absorption may increase when taken with food. C_max plasma levels reached after 1-4 hours after ingestion.

Oral bioavailability of Oratane is low which may be caused by parietal metabolism in the intestinal wall and the effect of "first passage" through the liver.

Oratane is highly bound to plasma proteins. Metabolized in the liver with the formation of the main metabolite 4-oxo-isotretinoin, also there is some isomerization of Oratane in tretinoin.

Oratane, tretinoin and its metabolites are enterohepatic recycling.

The end of T1/2 of tretinoin is 10-20 hours. An equivalent amount is determined in the feces, mostly unchanged, and urine in the form of metabolites.

Why is Oratane prescribed?

For Oratane oral administration: severe nodular-cystic acne especially with the localization on the body.

For rectal administration: severe relapsing forms of acne, rashes associated with seborrheic process.

For external use: papule-pustular acne, seborrhea, rosacea, perioral dermatitis.

Dosage and administration

For oral administration initial dose of Oratane is 500 mcg / kg / day; the maximum daily dose used for a limited time and is 1 mg / kg; the maintenance dose is 0.1-1 mg / kg / day; duration of treatment is 16 weeks, a second course conducted at intervals of 8 days. Oratane is taken with meals in one or more receptions.

Rectal - 0.5-1 mg / kg / day, one time at night ; course of treatment - 8-12 weeks, the intervals between courses - 1-2 months.

Ointment applied thinly to the affected areas of skin 2 times / day. Duration of treatment - 4-6 weeks.

Oratane side effects, adverse reactions

Dermatological reactions: dry mucous membranes, skin rashes, dermatitis, pruritus, cheilitis, erythema (especially on the face), sweating, palmar-plantar desquamation and paronychia, nail dystrophy, increased proliferation of granulation tissue in the affected area, rarely - thinning hair, vasculitis, photosensitivity.

Senses: conjunctivitis, photophobia, decreased night vision, corneal opacity, weakening of the hearing.

CNS and peripheral nervous system: headache, rarely - depression, seizures, suicide, and in rare cases - intracranial hypertension.

Digestive system: nausea, rarely - colitis, bleeding from the gastrointestinal tract, transient elevation of liver transaminases and in rare cases - hepatitis.

Hematopoietic system: anemia, neutropenia, changes in platelet count, increased erythrocyte sedimentation rate.

Metabolism: increased concentrations of TG and glucose.

Musculoskeletal system: pain in muscles and joints, rarely - hyperostosis.

Other: nasal bleeding.

Rectal and topical using: 1-2 weeks of treatment may cause new eruptions, itching, swelling and redness.

Oratane contraindications

Pregnancy, established and planned lactation, hypersensitivity to Oratane, the simultaneous use of tetracycline antibiotics.

For oral administration: severe liver and / or kidney damage, hypervitaminosis A, significantly elevated levels of lipids in blood plasma, neoplasms.

For rectal use - diseases of the rectum.

Using Oratane during pregnancy and lactation

Oratane has a pronounced teratogenic and embryotoxic action.

Oratane is contraindicated in established and planned pregnancy.

Also Oratane is contraindicated during lactation.

Special instructions

Rectally and topically applied with caution in liver disease, kidney disease, chronic pancreatitis, decompensation of heart function, chronic intoxication.

Rectal and external use in a pronounced exacerbation of the reaction (on 1-2-week treatment) is recommended to cancel the medication for a few days before its decline, then therapy can be resumed.

For oral administration requires regular monitoring of liver function and lipid levels in blood plasma before treatment, 1 month after initiation of therapy and then every 3 months.

In diabetes, obesity, alcoholism or lipid metabolism violations recommended more frequent monitoring of laboratory parameters. In diabetes mellitus or suspected it is necessary to strictly control glucose levels in plasma.

With prolonged use may develop symptoms of chronic hypervitaminosis A.

During treatment or within a certain time after its completion can not be donors for women of childbearing age.

During the treatment, patients should not be given UV treatment, patients should avoid direct exposure to sunlight.

In the course of treatment with Oratane may occur intolerance of contact lenses.

Safety of children and prepubertal patients has not been established.

Should avoid the simultaneous use of Oratane and 19-nortestosterone derivatives, particularly in patients with gynecological / endocrine diseases.

Not recommended for concurrent use of other drugs with keratolytic or exfoliative properties (including other retinoids), and progesterone in the microdose (including drugs "mini-pilly").

Oratane drug interactions

The action of Oratane is weakened by the simultaneous application of progesterone in the microdose.

With the simultaneous application of Oratane and vitamin A may increase toxic effects.

With the simultaneous application of Oratane and aminoglycoside antibiotics is at risk of developing intracranial hypertension.

Oratane pharmaceutical active ingredients containing related brand and generic drugs:

• Isotretinoin

Oratane available forms, composition, doses:

• Capsules; Oral; Isotretinoin 10 mg
• Capsules; Oral; Isotretinoin 20 mg
• Capsules; Oral; Isotretinoin 40 mg
• Capsules; Oral; Isotretinoin 5 mg

Oratane destination | category:

• Human:
• Acne treatment preparations
• Skin and mucous membrane agents

Oratane Anatomical Therapeutic Chemical codes:

• D10AD04 - Isotretinoin
• D10BA01 - Isotretinoin

Oratane pharmaceutical companies:

• Apex Pharma Marketing
• Darier Laboratorios Dermatologicos
• Douglas Pharmaceuticals
• Genepharm
• Grafton Pharmasia
• Hind Wing
• Pharmaplan
• Schmidt BioMedTech

References

1. Dailymed."SOTRET (ISOTRETINOIN) CAPSULE, GELATIN COATED SOTRET (ISOTRETINOIN) CAPSULE, LIQUID FILLED [RANBAXY LABORATORIES INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."ISOTRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "Isotretinoin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Oratane after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oratane not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology