Buprenorphine Teva Uses, Dosage, Side Effects& Precautions
Medicinal product withdrawn from the market on 06/16/2015
what is buprenorphine teva medication used for and indication?
This medication is exclusively reserved for the substitution treatment of major drug dependence on opiates, within the framework of medical and psycho-social monitoring, based on an agreement between the patient and his doctor.
This treatment is reserved for adults and children over 15 years who have volunteered to receive substitution treatment.
PRESENTATION (S) AVAILABLE FOR BUPRENORPHINE TEVA 1 MG
2 presentations are available for this medication:
- PVC-Aluminum blister pack (s) of 7 tablet (s)
- PVC-Aluminum blister pack (s) of 28 tablet (s)
|Pharmaceutical class||other central nervous system drugs|
|Active substance (s)||buprenorphine hydrochloride|
|Route (s) of administration||sublingual|
|Social security reimbursement rate||65%|
|Laboratory (s)||TEVA SANTE|
|Conditions of issue||available by simple prescription|
buprenorphine teva Dosage
- Administration in one dose per day.
- The doses are individual. They are gradually adapted under medical supervision, according to the needs of each patient.
- If you have the impression that the effect of BUPRENORPHINE TEVA 1 mg sublingual tablet is too strong or too weak, talk to your doctor or pharmacist.
buprenorphine teva Contraindications
Do not take BUPRENORPHINE TEVA 1 mg, sublingual tablet in the following cases:
- known allergy to buprenorphine or to any other component of the product,
- children under 15,
- severe respiratory failure,
- severe liver disease,
- acute alcohol poisoning or alcohol withdrawal syndrome (delirium tremens),
- in combination with methadone,
- in combination with level III opioid analgesics.
How To Take buprenorphine teva ?
Method and route of administration
- The sublingual route is the only effective and well-tolerated route for taking this drug.
- Allow the tablets to melt under the tongue.
- The tablets should not be swallowed.
Duration of treatment
The duration of treatment should be determined individually for each patient.
Stopping treatment, by gradually reducing the dosage, may be considered, with your consent, after your condition has stabilized sufficiently. The doses should be reduced in successive stages under the supervision of your doctor.
Do not change or stop treatment without the consent of your doctor.
The effectiveness of treatment depends on:
- the dosage,
- associated medico-psychological and socio-educational measures.
how does buprenorphine teva work?
MEDICINAL PRODUCT USED IN OPIACE DEPENDENCE, ATC code: N07BC01.
- Buprenorphine is an opioid agonist-antagonist and binds to the brain m and k receptors . Its activity in opioid substitution therapy is attributed to its slowly reversible binding to m receptors, which is said to prolong the need for drug addicts to be minimized.
- The partial agonist activity of buprenorphine gives the product a high therapeutic index by limiting its depressant effects, in particular on cardio-respiratory functions. The therapeutic margin of buprenorphine may be reduced in the event of combination with benzodiazepines or in situations of misuse of buprenorphine.
How To Store buprenorphine teva ?
Store at a temperature not exceeding 25 ° C.
buprenorphine teva Side Effects
Like all medicines, BUPRENORPHINE TEVA 1 mg, sublingual tablets can cause side effects, although not everybody gets them.
During a first administration, the occurrence of a withdrawal syndrome is possible.
The following side effects have been observed:
- Common side effects (1% -10%) : constipation, nausea, vomiting, insomnia, headache, malaise and dizziness, fatigue, drowsiness, drop in blood pressure when changing from lying or sitting to lying down or sitting down standing, sweating.
- Rare side effects (0.01% -0.1%) : respiratory failure, hallucinations, hepatitis (liver damage) with or without jaundice.
Intravenous misuse poses the risk of skin infection and severe acute hepatitis .
- Other post-marketing adverse reactions: hypersensitivity reactions (allergy), such as rash, pruritus (itching), bronchospasm (bronchial spasm), angioedema (swelling of the face and neck which may cause breathing difficulties) and anaphylactic shock (severe generalized allergic reaction).
- If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
- Keep out of the reach and sight of children.
buprenorphine teva Interactions
- Decrease in the effect of methadone by competitive blocking of receptors, with the risk of the appearance of a withdrawal syndrome.
Level III opioid analgesics
- Decrease in the analgesic effect of the morphine, by competitive blocking of receptors, with the risk of the appearance of a withdrawal syndrome.
Not recommended associations
- Alcohol enhancement of the sedative effect of buprenorphine. Impaired vigilance can make driving and using machines dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
- Risk of onset of withdrawal syndrome.
Associations to take into account
The association with benzodiazepines exposes to the risk of death by respiratory depression of central origin. Dosages should be limited and this combination avoided in the event of a risk of misuse.
Other central nervous system depressants:
other morphine derivatives (analgesics and cough suppressants), certain antidepressants, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related:
- Increase in central nervous system depression. Impaired vigilance can make driving and using machines dangerous.
- Possible exaggeration of the effects of opiates, by extrapolation from data on morphine.
- An interaction study between buprenorphine and ketoconazole (a strong inhibitor of CYP3A4) showed an increase in Cmax and AUC of buprenorphine (approximately 70% and 50% respectively) and, to a lesser extent, of norbuprenorphine. Therefore, patients treated with BUPRENORPHINE TEVA should be closely monitored if co-administered with strong CYP3A4 inhibitors such as HIV protease inhibitors (ritonavir, nelfinavir or indinavir), or azole antifungals (ketoconazole or itraconazole), and a reduction in the dose of BUPRENORPHINE TEVA may be necessary.
- Interactions between buprenorphine and CYP3A4 inducers have not been studied. Therefore, close monitoring is recommended in patients co-administered with CYP3A4 inducers (such as phenobarbital, carbamazepine, phenytoin and rifampicin).
- To date, no significant interaction of buprenorphine has been observed with cocaine, the drug most frequently associated with opiates in poly-drug addiction.
Effects on ability to Drive and use machines
Attention is drawn, especially among vehicle drivers and users of machines, to the risk of drowsiness associated with the use of this medication.
Warnings and Precautions
- This product can be the cause of fatal respiratory failure, especially when taken in combination with benzodiazepines (drugs indicated for anxiety or insomnia) and when used improperly.
- Cases of severe acute hepatitis (severe liver damage) have been reported with the misuse of BUPRENORPHINE TEVA, especially by the intravenous route and in high doses. These attacks may be favored by certain conditions such as viral infections (chronic hepatitis C), alcoholism, anorexia, or by certain associated drugs (for example: antiretrovirals, aspirin, amiodarone, isoniazid, valproic acid). In the event of the appearance of significant fatigue, itching or jaundice, consult your doctor so that he determines the origin and decides to continue the treatment under supervision or to organize its discontinuation.
- This product may cause withdrawal syndrome if administered less than 4 hours after taking a narcotic (morphine, heroin or related products).
- This product may cause drowsiness which may be increased by products such as alcoholic beverages, tranquilizers, sedative drugs, sleeping pills.
Tell your doctor if you have:
- recent head trauma
- low blood pressure
- in men: urinary disorders (in particular linked to an enlarged prostate).
This medicine may mask the pain signaling certain diseases. Remember to tell your doctor if you are taking this medicine.
This product may cause a drop in blood pressure when changing from lying down to standing.
This product may cause drug dependence.
Short-term prescription and dispensing are recommended, particularly at the start of treatment.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).
Precautions for use
Tell your doctor if you have:
- asthma or illness with respiratory failure,
- kidney disease,
- liver disease.
PREGNANCY & BREAST-FEEDING & FERTILITY
- The only data available do not indicate an increased risk of malformation associated with taking buprenorphine during the first trimester of pregnancy.
- Buprenorphine may be prescribed during pregnancy depending on the expected benefit versus the risk for the mother and the newborn. However, dosage adjustment may be necessary in order to maintain the therapeutic efficacy of the treatment.
- Chronic maternal intake of buprenorphine at any dose during the last three months of pregnancy can cause withdrawal syndrome in the newborn. In addition, high doses of buprenorphine in late pregnancy, even for brief treatment, are likely to cause respiratory depression in the newborn.
- Therefore, at the end of pregnancy, in case of occasional high dose doses or chronic administration, neonatal monitoring should be considered because of the risk of respiratory depression or withdrawal syndrome in the newborn.
Feeding with milk
- Due to the passage of buprenorphine and its metabolites in breast milk and insufficient clinical data, it is recommended, as a precaution, to avoid breast-feeding during treatment .
What happens if I overdose from buprenorphine teva ?
- The properties of partial morphine agonist of buprenorphine give it a high therapeutic index.
- In the event of accidental overdose, comprehensive management should be instituted, including close monitoring of the patient’s respiratory and cardiac status.
- The main symptom to be treated is respiratory depression, which can lead to respiratory arrest and death. If the patient vomits, precautions should be taken to avoid bronchial inhalation of digestive contents.
- Treatment: Symptomatic treatment of respiratory depression and intensive care measures should be implemented. Freedom of the upper airways should be ensured as well as controlled ventilation, or assisted if necessary. The patient must be transferred to an intensive care unit. The use of an opioid antagonist (naloxone) is recommended, despite its modest effect on the respiratory symptoms due to buprenorphine, the latter being strongly bound to the morphine receptors.
- In the event of administration of an opioid antagonist (naloxone), the long duration of action of the product should be taken into account.
What should I do if I miss a dose?
Seek the advice of the prescribing physician.
What is Forms and Composition ?
Appearance and shape
- Round, white, biconvex tablet debossed with “1” on one side, with an arrow debossed on the other side.
- 7 sublingual tablets in blister packs (PVC / Aluminum).
- BUPRENORPHINE ETHYPHARM six (6) mg, sublingual tablet, box of seven (7)
- BUPRENORPHINE TEVA two (2) mg, sublingual tablet, box of seven (7)
- BUPRENORPHINE TEVA eight (8) mg, sublingual tablet, box of seven (7)
- BUPRENORPHINE ETHYPHARM four (4) mg, sublingual tablet, box of seven (7)
Active ingredient Sublingual tablet
Buprenorphine 1 mg ** per unit dose
Excipients with known effects ? :
- Lactose monohydrate
- Mannitol, Corn starch, Citric acid anhydrous, Sodium citrate, Povidone K30, Sodium stearyl fumarate
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.