Soltus Tablets (Generic Amisulpride Tablets)

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Soltus Tablets (Generic Amisulpride Tablets)

Soltus (Generic Amisulpride tablets) is used for the
treatment of acute and chronic schizophrenic disorders,
which is a condition that affects the way you think, feel
and/or act.
Schizophrenia is an illness that can make you feel, see or hear
things which do not exist, have strange and frightening
thoughts, change how you act and make you feel alone.
Sometimes people with these symptoms may also feel tense,
anxious or depressed. Amisulpride works by improving
disturbed thoughts, feelings and behaviour.

Active Ingredient
The active ingredient present in Soltus tablets is Amisulpride.
Each Soltus tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400
mg of Amisulpride depending on the strength of the tablet.

Chemical Structure
The structure of Amisulpride is given below:

Soltus Tablets are manufactured by Intas Pharmaceuticals
Limited, India in the strength of 50 mg, 100 mg, 200 mg, 300
mg and 400 mg.
(Website: https://www.intaspharma.com/ )
URL: https://www.clearskypharmacy.biz/amisulpride-tablets.html

Amisulpride Tablets – Brand Names
Amisulpride Tablets are available under
various Drug trade names that include
Solian, Sulpitac, Amazeo, Amipride, Amival,
Soltus, Sulprix, Socian, Stozen, Sypride,
Stozen, Zulpride, Bipo Life, Zonapride,
Psyride, Amgrace and Amisure.

Uses of Soltus Tablets
Soltus Tablets (Generic Amisulpride Tablets) are used for the
treatment of acute and chronic schizophrenic disorders in
which positive symptoms (such as delusions, hallucinations
and thought disorders) and/or negative symptoms (such as
blunted effect, emotional and social withdrawal) are
prominent, including patients characterised by predominant
negative symptoms.

Soltus Tablets Dosage
The dosage of Soltus tablets (Generic Amisulpride Tablets) is
given below:
The recommended dosage is orally once a day if the dose is less than
400 mg, before meals. Swallow the tablets whole with a drink of
water. Do not chew your tablets. If the daily dose exceeds 400 mg, it is
to be administered as two divided doses.
If you suffer from predominant negative symptoms, oral doses between
50 mg/day and 300 mg/day are recommended. Doses should be
adjusted individually depending on the nature and severity of your
illness.

Soltus Tablets Dosage
The dosage of Soltus tablets (Generic Amisulpride Tablets)
is given below:
In case you suffer from positive symptoms, the usual dose is between
400 mg and 800 mg of Generic Amisulpride daily, and will be
adjusted individually by your doctor depending on the nature and
severity of your illness.
The maximum daily dose is 1,200 mg.
If you suffer from both positive and negative symptoms, your doctor
will adjust your dose individually so that there is adequate control of
the positive symptoms. To maintain treatment, your doctor will use
the lowest possible dose that is effective for you.

Contraindications
Soltus tablets are contraindicated in patients with a hypersensitivity
to or any other component of this medication.
Other contraindications of Soltus Tablets (Generic Amisulpride
tablets) include:
Concomitant prolactin-dependent tumours eg pituitary gland
prolactinomas and breast cancer.
Phaeochromocytoma.
Contraindicated in Children up to puberty.
Lactation.

Contraindications
Other contraindications of Soltus Tablets (Generic Amisulpride
tablets) include:
In combination with the following medication which could induce
torsades de pointes: Class Ia anti-arrhythmic agents such as
Quinidine and Disopyramide, Class III anti-arrhythmic agents such
as amiodarone and sotalol, Other medications such as cisapride,
intravenous Erythromycin, Pentamidine, Levodopa; reciprocal
antagonism between Levodopa and neuroleptics.
In hepatic impairment, Amisulpride may be contraindicated to
avoid the possible risk of adverse events due to an influence of the
disease on Amisulpride metabolism.

Storage Instructions
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to
77°F) with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Neuroleptic Malignant Syndrome, a potentially fatal syndrome, characterized
by hyperthermia, muscle rigidity, autonomic instability, altered consciousness
and elevated CPK, may occur. In the event of hyperthermia, particularly with
high daily doses, all antipsychotic drugs including Soltus tablets must be
stopped.
Amisulpride induces a dose-dependent prolongation of the QT interval. This
effect, known to potentiate the risk of serious ventricular arrhythmias,
particularly of the torsades de pointes type, is enhanced in patients with
bradycardia, hypokalemia, or congenital or acquired prolonged QT interval
(combination with a medicinal product which prolongs the QTc interval)
In randomized, placebo-controlled clinical studies in elderly patients with
dementia and treated with certain atypical antipsychotics agents, a threefold
risk of stroke was observed versus placebo.

Warnings
Cases of venous thromboembolism (VTE) have been reported with antipsychotic
drugs. Since patients treated with antipsychotic drugs often present acquired risk
factors for VTE, any potential risk factors for VTE must be identified before and
during treatment with and preventive measures should be taken.
Amisulpride may increase prolactin levels. Therefore, caution should be exercised and
patients with a history or a family history of breast cancer should be closely monitored
during Amisulpride therapy.
Hyperglycemia has been reported in patients treated with some atypical antipsychotic
agents, including Amisulpride, therefore patients with an established diagnosis of
diabetes mellitus or with risk factors for diabetes who are started on Amisulpride,
should get appropriate glycaemic monitoring.
Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose of
Soltus tablets must be decreased and intermittent treatment should be considered.

Warnings
Amisulpride can lower the seizure threshold. Therefore patients with a history
of seizures should be closely monitored during therapy with Soltus tablets.
In elderly patients, Soltus therapy, like other neuroleptics, must be used with
special caution because of a possible risk of hypotension or sedation.
Withdrawal symptoms have been described after abrupt cessation of high
therapeutic doses of antipsychotic drugs.
Leukopenia, neutropenia and agranulocytosis have been reported with
antipsychotics, including Soltus tablets. Unexplained infections or fever may
be evidence of blood dyscrasia and requires immediate haematological
investigation.
Caution should be also exercised when prescribing Soltus tablets to patients
with Parkinson’s disease since it may cause worsening of the disease.

Side Effects
If you notice either of the following serious Amisulpride (Soltus Tablets) side
effects you should stop taking the tablets and contact your doctor immediately:
You have a rash, itching, blistering or other effects on the skin, eyes, mouth or
genitals.
You get a high temperature, stiff/rigid muscles, a feeling of instability when you
try to move, fast heart rate and/or breathing or an increase in sweating
(symptoms of a condition called Neuroleptic Malignant Syndrome).
Blood clots in the veins especially in the legs (symptoms include swelling, pain
and redness in the leg), which may travel through blood vessels to the lungs
causing chest pain and difficulty in breathing.
If you notice any of these symptoms seek medical advice immediately.

Side Effects
Very common: affects more than 1 user in 10
Trembling
Pronounced muscle stiffness or spasm
Slowness of movement
Excess saliva or restlessness, which will usually be reduced if your doctor lowers
your dose of Amisulpride tablets or prescribes you an additional medicine.
Common: affects 1 to 10 users in 100
Weight gain
Abnormal movements such as tics or spasms in the muscles of the neck, eyes or
jaw which will be reduced if your doctor prescribes you an additional medicine
Drowsiness , Dizziness
Constipation, nausea, vomiting, dry mouth
Low blood pressure (causing dizziness)

Side Effects
Common: affects 1 to 10 users in 100
Increased levels of the hormone prolactin which can lead to milk secretion from
the breasts, breast pain or enlargement, menstrual period disorders, impotence,
which will gradually disappear after you stop taking Amisulpride Tablets and
prolactinoma (benign tumour of the pituitary gland)
Insomnia, anxiety, agitation, difficulty having sex or reaching orgasm.
Uncommon: affects 1 to 10 users in 1,000
Slow heart beat
Uncontrollable movements, mainly of the face or tongue (usually after long-term
treatment), convulsions (fits)
Increased liver enzyme levels, increased blood sugar levels (hyperglycaemia)
Allergic reactions such as skin rashes, itching or swelling.

Side Effects
Not known: frequency cannot be estimated from the available
data
Abnormal heart rhythms, which may be life-threatening and lead
to cardiac arrest and sudden death.
If any of the side effects gets serious or if you notice any side
effects not listed here, please tell your doctor or pharmacist.

Overdose
Exaggeration of the known pharmacological and adverse effects of
Amisulpride (Soltus Tablets) have been observed. These could
include drowsiness, sedation, hypotension, extrapyramidal
symptoms and coma. Fatal outcomes have been reported mainly in
combination with other psychotropic agents.
In cases of acute overdose, the possibility of multiple medicine
intake should be considered.

Overdose
There is no specific antidote to Amisulpride. Appropriate
supportive measure should therefore be instituted: close
supervision of vital functions and, because of the risk of
prolongation of QT interval, continuous cardiac monitoring
until the patient recovers.
In case severe extrapyramidal symptoms occur, anticholinergic
agents should be administered. Since Amisulpride is weakly
dialysed, haemodialysis is not recommended as a method of
elimination.

Soltus Tablets During Pregnancy
Amisulpride (Soltus tablets) has been classified by the US FDA as
Pregnancy Category C.
Very limited clinical data on pregnancies exposed to this medicine are
available therefore the safety of Amisulpride during human pregnancy
has not been established.
Use of the drug is not recommended during pregnancy unless the
benefits justify the potential risks. Neonates exposed to antipsychotics
(including Amisulpride tablets) during the third trimester of pregnancy
are at risk of adverse reactions including extrapyramidal and/or
withdrawal symptoms that could vary in severity and duration following
delivery.

For more details on
Soltus Tablets click here
Soltus Tablets (Generic Amisulpride Tablets) by Intas
Pharmaceuticals Limited, India.

Soltus Tablets (Generic Amisulpride Tablets)

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