Duartron®

Duartron®

Alleviation of mild to moderate osteoarthritis of the knee

This drug (with this brand and datasheet) is registered in Spain, but is also approved in other countries. For more information please contact us.

Duartron®

Alleviation of mild to moderate osteoarthritis of the knee.

Glucosamine is an endogenous substance and a normal constituent of the polysaccharide chain of the cartilage matrix and of the glucosaminoglycans of the synovial liquid. In vitro and in vivo studies have demonstrated that glucosamine stimulates the physiological synthesis of glycosaminoglicans and proteoglycans by means of chondrocytes and of hyaluronic acid by means of sinoviocytes.

1.       NAME OF THE MEDICINAL PRODUCT 

Duartron 625 mg, hard capsules 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride). 

For the full list of excipients, see section 6.1. 

3.       PHARMACEUTICAL FORM

Hard capsule

The hard gelatin capsules are brown and size No. 0EL

4.       CLINICAL PARTICULARS

4.1     Therapeutic indications

Relief of symptoms of mild to moderate osteoarthritis of the knee.

4.2        Posology and method of administration 

Posology

Adults (including the elderly):

The recommended dose is 2 capsules in a single dose (1,250 mg/day of glucosamine).

Glucosamine is not indicated for the treatment of acute pain. Pain relief may occur after several weeks of treatment, or even after a longer period of time. If no improvement appears after 2-3 months of treatment, continued treatment with glucosamine should be reconsidered.

Pediatric population:

 Due to the lack of safety and efficacy data, Duartron use is not recommended in children or adolescents under 18 years of age.

Kidney and/or liver failure:

No dose recommendations can be provided since no studies have been conducted in patients with kidney or liver impairment. 

Method of administration 

The capsules can be taken before, during or after a meal.

The capsules must be swallowed whole, not chewed, and with sufficient water.

4.3     Contraindications

Known hypersensitivity to glucosamine or to any of the excipients

It must not be administered to patients who are allergic to shellfish, since glucosamine is obtained from shellfish.

4.4     Special warnings and precautions for use 

A doctor must be consulted to rule out the presence of joint diseases for which other treatment should be considered.

In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.

In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.

A report on exacerbated asthma symptoms triggered after initiation of glucosamine therapy has been described (symptoms resolved after withdrawal of glucosamine). Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of asthma symptoms.

4.5     Interaction with other medicinal products and other forms of interaction

Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine has been reported. Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.

Concurrent treatment with glucosamine and tetracyclines may increase the absorption and serum concentration of the tetracyclines, but the clinical relevance of this interaction is probably limited.

Due to limited documentation on potential drug interactions with glucosamine, one should generally be aware of an altered response or concentration of concurrently used medicinal products.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no data on the use of glucosamine in pregnant women.

The animal studies conducted are insufficient in terms of reproductive toxicity. Glucosamine should not be used during pregnancy.

Breast Feeding

It is unknown whether glucosamine is excreted in breast milk.

The use of glucosamine during lactation is not recommended since no data is available on the safety of the newborn. 

4.7     Effects on ability to drive and use machines

No studies have been conducted on the effects on the ability to drive vehicles or operate machinery. If dizziness or drowsiness is experienced, driving vehicles and operating machinery is not recommended.

4.8        Undesirable effects

The most common adverse reactions associated with treatment with glucosamine are described below as “common” (defined as ≥1/100 and <1/10), “uncommon” (defined as ≥1/1000 and ≤1/100) and “not known” (defined as not possible to be estimated from the available data) and by System Organ Class. Within each frequency group, the adverse reactions are presented in decreasing order of seriousness. The reported adverse reactions are generally mild and transitory.

Nervous system disorders

Common: headache, tiredness.

Not known: dizziness.

Respiratory, chest and mediastinal disorders

Not known: asthma/exacerbation of asthma.

Gastrointestinal disorders

Common: nausea, abdominal pain, indigestion, diarrhea, constipation.

Not known: vomiting.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, flushing.

Not known: angioedema, urticaria.

Metabolism and nutrition disorders

Not known: inadequately controlled diabetes mellitus, hypercholesterolemia

General disorders and administration site conditions

Not known: edema/peripheral edema.

4.9     Overdose

No cases of overdose have been reported.

5.       PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids. ATC code: M01AX05.

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chain of cartilage matrix and synovial fluid glycosaminoglycans. In vitro and in vivo studies have shown that glucosamine stimulates the physiological synthesis of glycosaminoglycans and proteoglycans through the chondrocytes and of hyaluronic acid through synoviocytes.

The mechanism of action of glucosamine in humans is unknown.

The period to onset of response cannot be assessed. 

5.2     Pharmacokinetic properties 

Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvents.

The available information on the pharmacokinetics of glucosamine is limited. The absolute bioavailability is unknown. The volume of distribution is approximately 5 liters and the half-life after intravenous administration is approximately 2 hours. Approximately 38% of an intravenous dose is excreted in the urine as unchanged substance. 

The ADME (absorption, distribution, metabolism and excretion) of glucosamine has not been completely elucidated. 

5.3     Preclinical safety data

Non-clinical study data does not show special risks for humans according to the conventional pharmacology studies on safety, repeated dose toxicity and genotoxicity.

Reactions were only observed in the non-clinical studies with exposure considered above the human maximum, which indicates little relevance for its clinical use.

6.       PHARMACEUTICAL PARTICULARS

6.1     List of excipients 

Magnesium stearate.

Composition of the capsule:

Gelatin

Red iron oxide (E172)

Titanium dioxide (E171)

Black iron oxide (E172)

6.2     Incompatibilities

Not applicable.

6.3     Shelf life

36 months

6.4     Special precautions for storage

Do not store above 30ºC. Store in the original package in order to protect from moisture.

6.5        Nature and contents of container <and of the special equipment for its use, administration or implantation>

PVC/PVDC/aluminum blister packaged in a cardboard box.

Packages of 60 hard capsules (6 blisters containing ten capsules each) and 180 hard capsules (3 packages of 60 hard capsules).

Only certain package sizes may be marketed.

6.6     Special precautions for disposal

No special requirements.

7.       MARKETING AUTHORIZATION HOLDER

BIOIBÉRICA, S.A.

Ctra. Nacional II, Km. 680, 6

08389 Palafolls (Barcelona)

Spain

8.       MARKETING AUTHORIZATION NUMBER(S)

75658

9.       DATE FOR FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

April 2013

10.     DATE OF REVISION OF THE TEXT

January 2012

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Joint Health

E-mail address:
humanhealth@bioiberica.com
Telephone number:
+34 93 490 49 08
Fax:
+34 93 490 97 11