DULOXETINE – Combac 20mg

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Description

DULOXETINE (COMBAC-20, COMBAC-30, COMBAC-40, COMBAC-60) (Anti Depressant)

 

Duloxetine and its analogues , for example, the drug Simbalta or Duloxetine canon are well-proven drugs for the treatment and prevention of depression of various etiologies, neuropathy, including diabetic and other anxiety disorders. On request Simbalta reviews can be found on the net a lot of positive essays on taking the drug, on request duloxetine reviews there is a little less useful information. Nevertheless, in the past reviews, before taking the drug and before you buy duloxetine, carefully read the instructions and contraindications. On the site it is possible to buy an analogue of Simbalt – generic duloxetine with the brand name COMBAC-60 in the dosage of duloxetine 60 mg.

Simbalta instruction, duloxetine instruction:

Pharmacodynamics

Duloxetine is an antidepressant, a serotonin and norepinephrine reuptake inhibitor, and weakly inhibits dopamine uptake, without significant affinity for histaminergic, dopaminergic, cholinergic, and adrenergic receptors. The mechanism of action of duloxetine in the treatment of depression is to suppress the reuptake of serotonin and norepinephrine, resulting in increased serotonergic and noradrenergic neurotransmission in the CNS.

Duloxetine has a central mechanism for suppressing pain syndrome, which, first of all, is manifested by an increase in pain sensitivity in pain syndrome of neuropathic etiology.

Pharmacokinetics

Suction. Duloxetine is well absorbed when taken orally. Absorption begins 2 hours after taking the drug. The maximum concentration of the drug is achieved 6 hours after administration.
Meal does not affect the maximum concentration of the drug, but increases the time to reach the maximum concentration from 6 to 10 hours, which indirectly reduces the degree of absorption (approximately by 11%).
Distribution. 
Duloxetine binds well to plasma proteins (> 90%), mainly with albumin and α1 -globulin, but disorders of the liver or kidneys do not affect the degree of protein binding.
Metabolism.
Duloxetine is extensively metabolized, and its metabolites are mainly excreted in the urine. Both CYP2D6 and CYP1A2 catalyze the formation of two major metabolites (glucuronic conjugate 4-hydroxiduloxetine, sulfate conjugate 5-hydroxy, 6-methoxydioxetine).
Circulating metabolites do not possess pharmacological activity.
Derivation. The duration of the half-life of duloxetine is 12 hours. The average clearance of duloxetine is 101 l / h.  

Separate groups of patients. 
Gender:
although differences in pharmacokinetics between men and women were found (the average clearance of duloxetine is lower in women), these differences are not so great that there is a need for dose adjustment depending on gender. Age: although differences in pharmacokinetics between middle-aged and elderly patients were found (AUC – the area under the concentration / time curve is longer and the half-life of the drug is longer in the elderly), these differences are not enough to change the dose depending on the age of the patients.

Renal dysfunction:
in patients with severely impaired renal function (end-stage CRF – chronic renal failure) on hemodialysis, the values ​​of Cmax (maximum concentration) and AUC of duloxetine increased by 2 times. In this regard, it is necessary to consider the feasibility of reducing the dose of the drug in patients with clinically pronounced renal dysfunction.

Liver dysfunction:
in patients with clinical signs of liver failure, a slowdown in metabolism and duloxetine elimination may be observed. After a single dose of 20 mg of duloxetine in 6 patients with cirrhosis of the liver with moderate liver dysfunction (Child-Pugh class B), the half-life of duloxetine was about 15% higher than in healthy people of the corresponding sex and age with a fivefold increase in the average exposure ( AUC). Despite the fact that the Cmax of patients with cirrhosis was the same as that of healthy people, the half-life was about 3 times longer.

Indications for use

Depression.

Painful form of diabetic neuropathy.

Generalized Anxiety Disorder

Contraindications

Hypersensitivity to the drug.

Simultaneous use with monoamine oxidase inhibitors (IMAO) (see section “Special instructions”).

Uncompensated angle-closure glaucoma

With caution
In case of exacerbation of manic / hypomania state, epileptic seizures, mydriasis, abnormal liver function or kidney function, with the probability of suicidal attempts (see the section “Special Instructions”).

Use during pregnancy and breastfeeding

Due to lack of experience with duloxetine during pregnancy, the drug should be prescribed during pregnancy only if the potential benefit to the patient greatly exceeds the potential risk to the fetus. Patients should be warned that in case of occurrence or planning of pregnancy during the period of treatment with duloxetine, they should be informed about this by their doctor.
Due to the lack of experience with duloxetine in women during breastfeeding, breastfeeding is not recommended during duloxetine therapy.

Dosage and administration

Inside Capsules should be swallowed whole, not chewed or crushed. You can not add the drug in food or mix it with liquids, as this may damage the enteric shell of the pellets.

The recommended starting dose of duloxetine is 60 mg once a day, regardless of the meal. In some patients, to achieve a good result, it is necessary to increase the dose from 60 mg once a day to a maximum dose of 120 mg per day in two doses. A systematic assessment of the drug intake in a dose of more than 120 mg was not carried out.

In patients with renal insufficiency: the initial dose should be 30 mg 1 time per day in patients with severe impaired renal function (end-stage CRF) (creatinine clearance <30 ml / min).

In patients with impaired liver function: reduce the initial dose of the drug or reduce the frequency of intake in patients with cirrhosis.

Age: the use of the drug is recommended in patients ≥ 18 years.
There is no clinical experience with duloxetine in patients under 18 years of age.

Side effect

The most frequently (≥ 10%) in clinical studies were observed:
dizziness (except for vertigo), dry mouth, nausea, constipation, sleep disturbances (drowsiness or insomnia) and headache. Headache was less common than placebo.

Less commonly (from ≥ 1 to <10%) were noted: diarrhea, vomiting, tremor, loss of appetite, weight loss, weakness, increased sweating, hot flashes, blurred vision, anorgasmia, decreased libido, delayed and impaired ejaculation, and erectile dysfunction.

Dizziness, nausea, headache were noted as frequent adverse effects with the withdrawal of duloxetine.

Effect on glucose concentration in patients with the painful form of diabetic neuropathy: a slight increase in fasting blood glucose can be observed while taking duloxetine.

Overdose

Reported several cases of overdose with simultaneous ingestion of up to 1400 mg of the drug that did not have fatal consequences. Overdose can be accompanied by the following symptoms: tremor, clonic convulsions, ataxia, vomiting and loss of appetite.

Treatment with overdose. The specific antidote is not known. It is recommended to monitor cardiac activity and monitor key vital signs, along with symptomatic and supportive treatment.

Driving and performance of work requiring increased attention.
During the studies of duloxetine, no psychomotor reactions, cognitive functions, or memory were identified. However, the drug may be accompanied by drowsiness. In this regard, patients taking duloxetine, should be careful when driving dangerous mechanical means, including the car.

Release form

Capsules 30 mg or 60 mg.

Storage conditions

At a temperature of 15-30 ° C, in places inaccessible to children.

Shelf life

3 years.
Do not use later than the date indicated on the package.

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