Lobamine Cysteine in capsules contains 2 sulfur amino acids: DL-methionine at a rate of 350 mg and anhydrous cysteine hydrochloride at a rate of 150 mg. The excipients are anhydrous colloidal silica and magnesium stearate, while the capsule is composed of gelatin and titanium dioxide.
Lobamine Cysteine from Ducray laboratories belongs to the class of dermatological medicines.
This medicine is used as an adjunctive treatment for hair loss in adults .
Lobamine Cysteine Hair Dosage
The recommended dosage is 4 to 6 capsules per day in 2 to 3 doses for 1 month.
An overdose could lead to an increased risk of side effects (nausea, vomiting, irritability).
Precautions for use of Lobamine Cysteine capsules
This anti-hair loss medication should be used with caution in pregnant or breastfeeding women. Always seek the advice of your doctor before using it.
In patients with renal or hepatic insufficiency, Lobamine Cysteine should only be used on medical advice due to the risk of worsening an already established hepatic encephalopathy.
This medication should not be used against hair loss in cases of metabolic acidosis or homocystinuria.
In case of allergy to one of the components including the excipients (colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide), Lobamine Cysteine should not be taken.
Packaging : Box of 120 capsules
Please read the following full disclosure before taking or purchasing this item:
LOBAMINE CYSTEINE, capsule
- QUALITATIVE AND QUANTITATIVE COMPOSITION
DL-Methionine ............................................................... 350 mg
Anhydrous cysteine hydrochloride .............................. 150 mg
For a No. 0 capsule of 520 mg.
For the complete list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Capsule.
Capsule approximately 22 mm long and opaque white in color.
- CLINICAL DATA
4.1. Therapeutic Indications
Adjunct treatment of androgenic alopecia in adults.
4.2. Dosage and Administration
Dosage
4 to 6 capsules per day, in 2 to 3 doses.
Treatment duration: 1 month.
Pediatric population
No data available.
Method of administration
Oral route.
Preferably to be taken with meals.
4.3. Contraindications
- Hypersensitivity to DL-Methionine or anhydrous cysteine hydrochloride, or to any of the excipients listed in section 6.1.
- Metabolic acidosis
- Homocystinuria and/or hypermethioninemia (hereditary disorders of amino acid metabolism)
4.4. Special Warnings and Precautions for Use
Hepatic Impairment
- LOBAMINE CYSTEINE should be used with caution in patients with liver impairment.
- LOBAMINE CYSTEINE may worsen the condition of pre-existing hepatic encephalopathy in patients with liver impairment.
Renal Impairment
LOBAMINE CYSTEINE should be used with caution in patients with kidney impairment.
4.5. Interactions with Other Medications and Other Forms of Interaction
The data available to date do not suggest the existence of clinically significant interactions.
4.6. Fertility, Pregnancy, and Breastfeeding
Pregnancy
There are no data on the use of LOBAMINE CYSTEINE in pregnant women. Animal studies are insufficient to draw conclusions about reproductive toxicity (see section 5.3).
Neurological toxicity has been reported in children with congenital hereditary hypermethioninemia. Additionally, elevated homocysteine resulting from the metabolism of dietary methionine has been associated in several studies with a risk of preeclampsia, neural tube defects, and intrauterine growth retardation. The relevance of these observations for the use of LOBAMINE CYSTEINE is difficult to assess.
As a precaution and given the indication, it is preferable to avoid the use of LOBAMINE CYSTEINE during pregnancy.
Breastfeeding
Methionine and cysteine are naturally present in breast milk. With high intake of methionine and cysteine, the risk of overdose in newborns/infants cannot be excluded. The decision to discontinue breastfeeding or to discontinue treatment with LOBAMINE CYSTEINE should be made considering the benefits of breastfeeding for the child and the benefits of the treatment for the mother.
Fertility
No animal or human data are available to exclude a potential effect of DL-Methionine or L-cysteine hydrochloride on male or female fertility.
4.7. Effects on the Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
Within each system organ class, adverse effects are presented by preferred MedDRA term in decreasing order of frequency, according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000), frequency not known (cannot be estimated from available data).
System organ classes
Preferred MedDRA term
Frequency not known
-
Nervous system disorders
- Headaches
-
Gastrointestinal disorders
- Nausea
- Diarrhea
- Abdominal pain
The adverse effects mentioned above are mostly mild and transient.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows for continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement.sante.gouv.fr.
4.9. Overdose
No cases of overdose have been reported. A potential overdose may lead to an exacerbation of adverse effects (nausea, vomiting, and irritability), in which case symptomatic treatment should be administered.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: AMINO ACIDS, INCLUDING COMBINATIONS WITH POLYPEPTIDES, ATC code: V06DD
Provides two sulfur-containing amino acids: methionine and cysteine.
5.2. Pharmacokinetic Properties
Absorption
Methionine is well absorbed by the gastrointestinal tract.
Metabolism
Methionine is metabolized in the liver to S-adenosylmethionine and then to homocysteine. Homocysteine is either remethylated to methionine or converted into taurine and cysteine.
Elimination
Methionine has a half-life of approximately 1 to 1.5 hours. About 5 to 10% of a dose is excreted unchanged in the urine, and about 80% is excreted as inorganic sulfate.
5.3. Preclinical Safety Data
DL-Methionine
Acute toxicity of DL-methionine is low via oral administration in rats and mice, with an LD50 greater than 2000 mg/kg. Similarly, DL-methionine administered for 90 days to rats at up to 2% of their diet, corresponding to approximately 1500 mg/kg/day, showed no adverse clinical or histopathological effects. Methionine has not shown genotoxic potential in evaluations conducted in vitro and in vivo. Methionine does not have carcinogenic potential.
No conventional reproductive and developmental toxicity studies are available. Published studies report adverse effects on offspring development in rats with chemically induced hypermethioninemia during gestation (facial dysmorphia, muscle atrophy, neurological disorders, brain histology alterations); the clinical relevance of these non-clinical observations is unknown.
L-cysteine hydrochloride
The acute toxicity of L-cysteine hydrochloride is low via oral administration in rats, with an LD50 greater than 2000 mg/kg. A combined chronic toxicity and carcinogenicity study of L-cysteine hydrochloride administered at 0.25 or 0.5% in drinking water was conducted in rats. Non-neoplastic nephrotoxicity was observed at the high dose, but no neoplastic effects attributable to the test substance were found, even at the highest administered dose. Despite positive results in some strains evaluated in the Ames test, L-cysteine was negative in both in vitro tests on mammalian cells and in an in vivo mouse micronucleus test. Additionally, L-cysteine was not carcinogenic. Conventional reproductive and developmental toxicity studies are not available.
- PHARMACEUTICAL DATA
6.1. List of Excipients
Colloidal anhydrous silica, magnesium stearate.
Capsule composition: gelatin, titanium dioxide.
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
3 years.
6.4. Special Precautions for Storage
No special storage conditions.
6.5. Nature and Contents of Container
Blister pack (PVC/aluminum) containing 10 capsules. Box of 20, 60, or 120 capsules.
6.6. Special Precautions for Disposal and Handling
No special requirements.
- MARKETING AUTHORIZATION HOLDER
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
- MARKETING AUTHORIZATION NUMBER(S)
- 34009 306 259 1 0: capsules in blister packs (PVC/Aluminum), box of 20.
- 34009 306 261 6 0: capsules in blister packs (PVC/Aluminum), box of 60.
- 34009 364 624 0 3: capsules in blister packs (PVC/Aluminum), box of 120.
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
[To be completed later by the holder]
- DATE OF TEXT REVISION
[To be completed later by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND DISPENSING CONDITIONS
Medicine not subject to a medical prescription.
