What is Shin-Naito S?
Shin-Naito S is used to treat and prevent erythema nodosum leprosum (ENL), a painful skin disease associated with leprosy. It is also used together with dexamethasone (eg, Decadron®) to treat patients with multiple myeloma (a cancer of the blood). Shin-Naito S works on the immune system to reduce inflammation. It also interferes with the growth of multiple myeloma cells, which are eventually destroyed in the body. Shin-Naito S is an antineoplastic (cancer medicine) and leprostatic agent.
This medicine is available only with your doctor's prescription. The Shin-Naito S® product is only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Shin-Naito S is used in certain patients with the following medical conditions:
- Esophagus ulcers in patients with human immunodeficiency virus (HIV) infection.
- Multiple myeloma in newly diagnosed patients who are elderly or cannot have transplant surgery, in combination with oral melphalan and prednisone chemotherapy.
Shin-Naito S indications
Multiple Myeloma
Shin-Naito S in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).
Erythema Nodosum Leprosum
Shin-Naito S is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).
Shin-Naito S is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.
Shin-Naito S is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
How should I use Shin-Naito S?
Use Shin-Naito S as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- Shin-Naito S comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Shin-Naito S refilled.
- Shin-Naito S can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Shin-Naito S. Ask your doctor or pharmacist if you have any questions about this program or how to use Shin-Naito S.
- Swallow Shin-Naito S whole with water. Do not break, crush, or chew before swallowing.
- Take Shin-Naito S by mouth at least 1 hour after eating your evening meal.
- If you are taking 1 dose daily, take it at bedtime, unless your doctor tells you otherwise.
- Do not open the capsules or handle Shin-Naito S more than necessary. Keep Shin-Naito S in the blister pack until just before you are ready to take it. If you touch a capsule that has been opened or get the powder on your skin, wash the area with soap and water right away.
- Women who are able to become pregnant (including those who have started menopause within the last 24 months), must use at least 2 methods of effective birth control while taking Shin-Naito S, unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Shin-Naito S, while taking Shin-Naito S, and for 4 weeks after stopping Shin-Naito S. Talk with your doctor about which methods of effective birth control may be appropriate for you.
- Men who take Shin-Naito S must use a latex or synthetic condom during any sexual contact with a woman who is pregnant or could become pregnant for as long as they are taking Shin-Naito S and for 4 weeks after stopping Shin-Naito S. This includes men who have had a vasectomy.
- Continue to use Shin-Naito S even if you feel well. Do not miss any doses.
- If you miss a dose of Shin-Naito S, take it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Shin-Naito S.
Uses of Shin-Naito S in details
Use: Labeled Indications
Erythema nodosum leprosum: Acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum; maintenance treatment for prevention and suppression of cutaneous manifestations of erythema nodosum leprosum recurrence
Limitation of use: Shin-Naito S is not indicated as monotherapy for erythema nodosum leprosum treatment in the presence of moderate to severe neuritis.
Multiple myeloma: Treatment of newly diagnosed multiple myeloma (in combination with dexamethasone)
Off Label Uses
AIDS-related aphthous stomatitis
Data from a double-blind, randomized, placebo-controlled trial in HIV-infected patients with oral aphthous ulcers support the use of Shin-Naito S for this condition.
Shin-Naito S description
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Shin-Naito S displays immunosuppresive and anti-angiogenic activity. It inhibits release of tumor necrosis factor-alpha from monocytes, and modulates other cytokine action. [PubChem]
Shin-Naito S dosage
Shin-Naito S Dosage
Generic name: Shin-Naito S 50mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Shin-Naito S® (Shin-Naito S) MUST ONLY BE ADMINISTERED IN COMPLIANCE WITH ALL OF THE TERMS OUTLINED IN THE Shin-Naito S REMS PROGRAM. Shin-Naito S® (Shin-Naito S) MAY ONLY BE PRESCRIBED BY PRESCRIBERS CERTIFIED WITH THE Shin-Naito S REMS PROGRAM AND MAY ONLY BE DISPENSED BY PHARMACISTS CERTIFIED WITH THE Shin-Naito S REMS PROGRAM.
Drug prescribing to females of reproductive potential should be contingent upon initial and continued confirmed negative results of pregnancy testing.
Consider dose reduction, delay, or discontinuation in patients who develop NCI CTC (National Cancer Institute Common Toxicity Criteria) Grade 3 or 4 adverse reactions and/or based on clinical judgment.
Multiple Myeloma
Shin-Naito S is administered in combination with dexamethasone in 28-day treatment cycles. The dose of Shin-Naito S is 200 mg administered orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days.
Patients who develop adverse reactions such as constipation, somnolence, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these adverse reactions, the drug may be started at a lower dose or at the previous dose based on clinical judgment.
Erythema Nodosum Leprosum
For an episode of cutaneous ENL, Shin-Naito S dosing should be initiated at 100 to 300 mg/day, administered once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should be started at the low end of the dose range.
In patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction, Shin-Naito S dosing may be initiated at higher doses up to 400 mg/day once daily at bedtime or in divided doses with water, at least 1 hour after meals.
In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with Shin-Naito S. Steroid usage can be tapered and discontinued when the neuritis has ameliorated.
Dosing with Shin-Naito S should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks.
Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.
More about Shin-Naito S (Shin-Naito S)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- En Espanol
- 0 Reviews - Add your own review/rating
Consumer resources
- Shin-Naito S
- Shin-Naito S (Advanced Reading)
Professional resources
- Shin-Naito S (AHFS Monograph)
- Shin-Naito S (FDA)
Related treatment guides
- Multiple Myeloma
- Leprosy, Erythema Nodosum Leprosum
Shin-Naito S interactions
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What other drugs will affect Shin-Naito S?
Shin-Naito S is not a substrate for cytochrome P450 (CYP450) isoenzymes and does not inhibit or induce human CYP450 enzymes in vitro. Therefore, pharmacokinetic drug-drug interactions are not anticipated when Shin-Naito S is coadministered with drugs that are substrates, inhibitors or inducers of cytochrome P450.
Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, Or Other CNS Depressants (Including Alcohol)
The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Shin-Naito S may cause an additive sedative effect and should be avoided.
Drugs Which Cause Bradycardia
The use of drugs which slow cardiac conduction concomitantly with Shin-Naito S may cause an additive bradycardic effect and should be used with caution. Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin. Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine).
In 16 healthy men, the pharmacokinetic profile of a single 0.5 mg digoxin dose was similar with and without the coadministration of Shin-Naito S 200 mg/day at steady state levels. The single dose of digoxin had no effect on the pharmacokinetic profile of Shin-Naito S. The safety of long-term concomitant use of Shin-Naito S and digoxin has not been evaluated.
Drugs Which Cause Peripheral Neuropathy
The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution.
Hormonal Contraceptives
Hormonal contraceptives increase the risk of thromboembolism. It is not known whether concomitant use of hormonal contraceptives further increases the risk of thromboembolism with Shin-Naito S.
In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 75 μg of ethinyl estradiol were studied. The results were similar with and without coadministration of Shin-Naito S 200 mg/day to steady-state levels.
Warfarin
In 13 healthy men, the pharmacokinetic profile and international normalized ratio (INR) of prothrombin time for warfarin, following a single oral dose of 25 mg, were similar with and without the coadministration of Shin-Naito S 200 mg/day at steady-state levels. The single dose of warfarin had no effect on the pharmacokinetic profile of Shin-Naito S.
Drugs That Interfere With Hormonal Contraceptives
Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John's Wort with hormonal contraceptive agents may reduce the effectiveness of the contraception up to one month after discontinuation of these concomitant therapies. Therefore, females requiring treatment with one or more of these drugs must use two OTHER effective or highly effective methods of contraception while taking Shin-Naito S.
Concomitant Therapies That May Increase The Risk Of Thromboembolism
Erythropoietic agents, or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies, should be used with caution in multiple myeloma patients receiving Shin-Naito S with dexamethasone.
Drug Abuse And Dependence
Physical and psychological dependence has not been reported in patients taking Shin-Naito S; however, as with other tranquilizers/hypnotics, Shin-Naito S has been reported to result in habituation to its soporific effects.
Shin-Naito S side effects
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What are the possible side effects of Shin-Naito S?
Applies to Shin-Naito S: oral capsule
As well as its needed effects, Shin-Naito S (the active ingredient contained in Shin-Naito S) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Shin-Naito S, check with your doctor immediately:
More common:
- Anxiety
- chest pain
- cough
- dizziness or lightheadedness
- fainting
- fast heartbeat
- muscle weakness
- pain, redness, or swelling in the arm or leg
- sudden shortness of breath or troubled breathing
- tingling, burning, numbness, or pain in the hands, arms, feet, or legs
- Blood in the urine
- decreased urination
- fever, alone or with chills and sore throat
- irregular heartbeat
- low blood pressure
- skin rash
- Blistering of the skin
- confusion
- convulsions
- difficulty with speaking
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- itching skin
- muscle jerking of the arms and legs
- peeling and loosening of the skin
- red skin lesions, often with a purple center
- red, irritated eyes
- slow speech
- sores, ulcers, or white spots in the mouth or on the lips
- sudden loss of consciousness
Minor Side Effects
Some Shin-Naito S side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
- Constipation
- diarrhea
- drowsiness
- nausea
- stomach pain
- Dry skin
- dryness of the mouth
- headache
- increased appetite
- mood changes
Shin-Naito S contraindications
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What is the most important information I should know about Shin-Naito S?
Pregnancy: Category X
Due to its known human teratogenicity, even following a single dose, Shin-Naito S is contraindicated in pregnant women and women capable of becoming pregnant. When there is no alternative treatment, women of childbearing potential may be treated with Shin-Naito S provided adequate precautions are taken to avoid pregnancy. Women must commit either to abstain continuously from heterosexual sexual contact or to use two methods of reliable birth control, including at least one highly effective method (e.g., IUD, hormonal contraception, tubal ligation, or partners vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to initiating treatment with Shin-Naito S, during therapy with Shin-Naito S, and continuing for 4 weeks following discontinuation of Shin-Naito S therapy. If hormonal or IUD contraception is medically contraindicated, two other effective or highly effective methods may be used.
Women of childbearing potential being treated with Shin-Naito S should have a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed within the 24 hours prior to beginning Shin-Naito S therapy and then weekly during the first 4 weeks of Shin-Naito S therapy, then at 4 week intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding. If pregnancy occurs during Shin-Naito S treatment, Shin-Naito S must be discontinued immediately. Under these conditions, the patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Because Shin-Naito S is present in the semen of patients receiving the drug, males receiving Shin-Naito S must always use a latex condom during any sexual contact with women of childbearing potential. The risk to the fetus from the semen of male patients taking Shin-Naito S is unknown.
Shin-Naito SÒ (Shin-Naito S) is contraindicated in patients who have demonstrated hypersensitivity to the drug and its components.
Active ingredient matches for Shin-Naito S:
List of Shin-Naito S substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Sedoval | |
| Shinnibrol | |
| Sleepan | |
| Slipro | |
| Softenil | |
| Softenon | |
| Synovir | |
| Talargan | |
| Talidomida Lazar (Ecuador) | |
| Talidomide Pharmion (Romania) | |
| Talimol | |
| Talimyde (India) | |
| Talimyde 100mg CAP / 10 (Shantha Biotechnics Pvt Ltd) | $ 11.93 |
| Talimyde 100 mg Capsule (Shantha Biotechnics Pvt Ltd) | $ 0.66 |
| TALIMYDE 100MG TABLET 1 strip / 10 tablets each (Shantha Biotechnics Pvt Ltd) | $ 9.04 |
| TALIMYDE cap 100 mg x 10's (Shantha Biotechnics Pvt Ltd) | $ 11.93 |
| Talimyde 100mg Tablet (Shantha Biotechnics Pvt Ltd) | $ 0.90 |
| Talismol | |
| Talizer (Georgia, Mexico) | |
| Tablet; Oral; Thalidomide 25 mg (Serral) | |
| Tablet; Oral; Thalidomide 50 mg (Serral) | |
| Tablet; Oral; Thalidomide 100 mg (Serral) | |
| Tablet; Oral; Thalidomide 200 mg (Serral) | |
| Telagan | |
| Telargan | |
| Telargean | |
| Tensival (Portugal) | |
| Thaangio (India) | |
| Thaangio 100mg CAP / 10 (Dr Reddy Laboratories Ltd) | $ 9.76 |
| Thaangio 100mg CAP / 30 (Dr Reddy Laboratories Ltd) | $ 29.28 |
| Thaangio 100 mg Capsule (Dr Reddy Laboratories Ltd) | $ 0.84 |
| THAANGIO 100 MG CAPSULE 1 strip / 30 capsules each (Dr Reddy Laboratories Ltd) | $ 27.84 |
| THAANGIO 100 MG CAPSULE 1 strip / 10 capsules each (Dr Reddy Laboratories Ltd) | $ 9.28 |
| THAANGIO 50 MG CAPSULE 1 strip / 10 capsules each (Dr Reddy Laboratories Ltd) | $ 4.64 |
| THAANGIO cap 100 mg x 10's (Dr Reddy Laboratories Ltd) | $ 9.64 |
| THAANGIO cap 100 mg x 30's (Dr Reddy Laboratories Ltd) | $ 28.71 |
| Thaangio 50mg Capsule (Dr Reddy Laboratories Ltd) | $ 0.46 |
| Thado (Taiwan) | |
| Thado 50 mg x 60's | |
| Thaled (Japan) | |
| Thalide (India) | |
| Thalide 50mg CAP / 10 (United Biotech) | |
| Thalide 100mg CAP / 10 (United Biotech) | |
| Thalide 200mg CAP / 10 (United Biotech) | |
| THALIDE 100 MG CAPSULE 1 strip / 10 capsules each (United Biotech) | $ 9.37 |
| THALIDE 200MG CAPSULE 1 strip / 10 capsules each (United Biotech) | $ 12.05 |
| THALIDE cap 50 mg x 10's (United Biotech) | $ 5.72 |
See 210 substitutes for Shin-Naito S | |
References
- DailyMed. "THALIDOMIDE: 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/dailyme... (accessed September 17, 2018).
- PubChem. "thalidomide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "thalidomide". http://www.drugbank.ca/drugs/DB01041 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Shin-Naito S are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Shin-Naito S. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
