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Dexamethasone 8 mg. 20 tablets

Product Code: Dexamethasone 8 mg. 20 tablets
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What Dexamethasone Teva is and what it is used for
Dexamethasone Teva is a synthetic glucocorticoid (a hormone released by the cortex of the adrenal glands) with an effect on metabolism, electrolyte balance and tissue functions.

Dexamethasone Teva is used for:
Diseases that require systemic treatment with glucocorticoids. These include, depending on the type and severity, the following:

cerebral edema caused by brain tumors, neurosurgery, brain abscess
severe acute asthma attack
initial treatment of extensive, severe, acute skin diseases including erythroderma, pemphigus vulgaris, acute eczema
certain inflammations of the blood vessels (systemic vasculitis such as polyarteritis nodosa)
treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus
severe progressive form of active rheumatic joint inflammation (rheumatoid arthritis), e.g. forms that rapidly lead to joint destruction and/or where tissue outside the joint is affected
rheumatoid arthritis in children (juvenile idiopathic arthritis)
rheumatic fever with inflammation of the heart
severe infectious diseases with poisoning-like conditions (e.g. tuberculosis, typhus, only as an adjunct to relevant anti-infective therapy)
supportive treatment for malignant tumors
prevention and treatment of vomiting due to cytostatic therapy
Dexamethasone Teva 4 mg Tablets: This medicine is used to treat coronavirus disease 2019 (COVTO-19) in adult and adolescent patients aged 12 years and older with a body weight of at least 40 kg) with difficulty breathing who require oxygen therapy.
2. What you need to know before you take Dexamethasone Teva
Do not take Dexamethasone Teva
if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexamethasone Teva.

Treatment with glucocorticoids can lead to reduced activity of the adrenal cortex (when the body does not produce enough glucocorticoids), which, depending on the dose and duration of treatment, can last for several months, and in some cases more than a year, after stopping of glucocorticoid treatment. If particularly stressful situations for the body occur during treatment with glucocorticoids, for example, febrile conditions, trauma or surgery, childbirth, etc., a doctor should be consulted or an emergency doctor should be informed about the treatment being carried out. A temporary increase in the daily dose of dexamethasone may be necessary. In the case of persistent insufficiency of the cortex of the adrenal glands after the end of treatment, additional administration of glucocorticoids may be necessary in physically stressful situations. If you are on long-term treatment with dexamethasone, your doctor will give you a corticosteroid identifier that you should always carry with you.

To avoid treatment-induced acute adrenal insufficiency, your doctor will provide you with a dose reduction schedule that you must strictly follow before the planned end of treatment.

Through the negative effect on the body's defenses, treatment with dexamethasone can lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections. Signs and symptoms of an existing or developing infection may be masked and therefore more difficult to recognize.

In the following diseases, treatment with dexamethasone should only be started if your doctor considers it absolutely necessary. If necessary, specific drugs with action against pathogens should also be taken:

acute viral diseases (chicken pox, herpes zoster, herpes simplex infections, corneal inflammation caused by herpes viruses)
HBsAg-positive chronic active hepatitis (infectious liver inflammation)
about 8 weeks before and up to 2 weeks after vaccination with attenuated pathogens (live vaccine)
acute and chronic bacterial infections
fungal infections that affect internal organs
some diseases caused by parasites (amoeba infections, worms). In patients with suspected or confirmed roundworm (nematode) infections, dexamethasone may lead to activation and massive proliferation of these parasites
poliomyelitis
lymph node disease after tuberculosis vaccination
with a history of tuberculosis, to be used only in combination with anti-tuberculosis drugs
if you have suspected or confirmed pheochromocytoma (tumor of the adrenal gland).
The following diseases should be under special observation during concomitant treatment with dexamethasone and treated as required:

ulcers of the gastrointestinal tract
bone loss (osteoporosis)
severe heart failure
high blood pressure that is difficult to regulate
diabetes (diabetes mellitus) that is difficult to regulate
mental (psychological) disorder
What Dexamethasone Teva is and what it is used for
Dexamethasone Teva is a synthetic glucocorticoid (a hormone released by the cortex of the adrenal glands) with an effect on metabolism, electrolyte balance and tissue functions.

Dexamethasone Teva is used for:
Diseases that require systemic treatment with glucocorticoids. These include, depending on the type and severity, the following:

cerebral edema caused by brain tumors, neurosurgery, brain abscess
severe acute asthma attack
initial treatment of extensive, severe, acute skin diseases including erythroderma, pemphigus vulgaris, acute eczema
certain inflammations of the blood vessels (systemic vasculitis such as polyarteritis nodosa)
treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus
severe progressive form of active rheumatic joint inflammation (rheumatoid arthritis), e.g. forms that rapidly lead to joint destruction and/or where tissue outside the joint is affected
rheumatoid arthritis in children (juvenile idiopathic arthritis)
rheumatic fever with inflammation of the heart
severe infectious diseases with poisoning-like conditions (e.g. tuberculosis, typhus, only as an adjunct to relevant anti-infective therapy)
supportive treatment for malignant tumors
prevention and treatment of vomiting due to cytostatic therapy
Dexamethasone Teva 4 mg Tablets: This medicine is used to treat coronavirus disease 2019 (COVTO-19) in adult and adolescent patients aged 12 years and older with a body weight of at least 40 kg) with difficulty breathing who require oxygen therapy.
2. What you need to know before you take Dexamethasone Teva
Do not take Dexamethasone Teva
if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexamethasone Teva.

Treatment with glucocorticoids can lead to reduced activity of the adrenal cortex (when the body does not produce enough glucocorticoids), which, depending on the dose and duration of treatment, can last for several months, and in some cases more than a year, after stopping of glucocorticoid treatment. If particularly stressful situations for the body occur during treatment with glucocorticoids, for example, febrile conditions, trauma or surgery, childbirth, etc., a doctor should be consulted or an emergency doctor should be informed about the treatment being carried out. A temporary increase in the daily dose of dexamethasone may be necessary. In the case of persistent insufficiency of the cortex of the adrenal glands after the end of treatment, additional administration of glucocorticoids may be necessary in physically stressful situations. If you are on long-term treatment with dexamethasone, your doctor will give you a corticosteroid identifier that you should always carry with you.

To avoid treatment-induced acute adrenal insufficiency, your doctor will provide you with a dose reduction schedule that you must strictly follow before the planned end of treatment.

Through the negative effect on the body's defenses, treatment with dexamethasone can lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections. Signs and symptoms of an existing or developing infection may be masked and therefore more difficult to recognize.

In the following diseases, treatment with dexamethasone should only be started if your doctor considers it absolutely necessary. If necessary, specific drugs with action against pathogens should also be taken:

acute viral diseases (chicken pox, herpes zoster, herpes simplex infections, corneal inflammation caused by herpes viruses)
HBsAg-positive chronic active hepatitis (infectious liver inflammation)
about 8 weeks before and up to 2 weeks after vaccination with attenuated pathogens (live vaccine)
acute and chronic bacterial infections
fungal infections that affect internal organs
some diseases caused by parasites (amoeba infections, worms). In patients with suspected or confirmed roundworm (nematode) infections, dexamethasone may lead to activation and massive proliferation of these parasites
poliomyelitis
lymph node disease after tuberculosis vaccination
with a history of tuberculosis, to be used only in combination with anti-tuberculosis drugs
if you have suspected or confirmed pheochromocytoma (tumor of the adrenal gland).
The following diseases should be under special observation during concomitant treatment with dexamethasone and treated as required:

ulcers of the gastrointestinal tract
bone loss (osteoporosis)
severe heart failure
high blood pressure that is difficult to regulate
diabetes (diabetes mellitus) that is difficult to regulate
mental (psychological) disorder
Dexamethasone can prolong the muscle relaxant effect of some drugs (non-depolarizing muscle relaxants).
Dexamethasone may increase the effect of some drugs to increase eye pressure (atropine and other anticholinergics).
Dexamethasone can reduce the effect of medicines to treat parasitic diseases (praziquantel).
During the simultaneous use of drugs for malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), dexamethasone may increase the risk of muscle diseases or diseases of the heart muscle (myopathies, cardiomyopathies).
Dexamethasone may reduce the effect of growth hormones (somatropin) especially at high doses or long-term treatment.
Dexamethasone may reduce the increase in thyroid-stimulating hormone (TSH) following protirelin (TRH, midbrain hormone) administration.
If used together with medicines that suppress the body's immune system (immunosuppressants), dexamethasone can increase vulnerability to infections and worsen existing infections that may not yet have manifested themselves.
Additionally, for cyclosporine (a medicine used to suppress the immune system): dexamethasone may increase the concentration of cyclosporine in the blood and thus the risk of convulsions.
Fluoroquinolones, a known group of antibiotics, can increase the risk of tendon rupture.
Effects on research methods
Glucocorticoids can suppress skin reactions in allergy tests.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Pregnancy
Dexamethasone crosses the placenta. During pregnancy, especially during the first three months, the drug should be used only after a careful assessment of the benefit-risk ratio. Therefore, it is necessary for women to inform the doctor if they are pregnant or if they become pregnant. During long-term treatment with glucocorticoids during pregnancy, fetal growth disorders cannot be excluded. If glucocorticoids are administered towards the end of pregnancy, there is a risk of adrenal insufficiency in the neonate, which may necessitate the use of replacement therapy in the neonate, which must be slowly tapered.

Breastfeeding
Glucocorticoids, including dexamethasone, are excreted in breast milk. No harmful effects on the infant have been reported so far. However, the need for treatment during breastfeeding should be carefully considered. If the disease requires the administration of higher doses, breastfeeding should be discontinued. Contact your doctor immediately.

Driving and using machines
So far, there is no evidence that dexamethasone affects the ability to drive, use machines or work without a secure support.

Dexamethasone Teva contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking dexamethasone.

3. How to take Dexamethasone Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Take this medicine exactly as prescribed, or dexamethasone may not work properly. If you are not sure, ask your doctor or pharmacist.

Unless your doctor has prescribed otherwise, the usual doses are:
Cerebral edema:
16-24 mg (up to 48 mg) (4-6 (up to 12) tablets) per day, divided into 3-4 (up to 6) individual doses for 4-8 days.

Severe and acute asthma attack:
Adults: 8-20 mg (2-5 tablets) as soon as possible, if necessary 8 mg (2 tablets) every 4 hours. Children: 0.15-0.3 mg/kg body weight.

Acute skin disease:
Depending on the nature and degree of the disease, a daily dose of 8-40 mg (2-10 tablets) up to 100 mg in individual cases, followed by treatment with decreasing doses.

Inflammation of a blood vessel such as polyarteritis nodosa:
6-16 mg/day (1½ - 4 tablets).

Systemic lupus erythematosus:
6-16 mg/ (1 ½ - 4 tablets).

A severe progressive form of active rheumatoid arthritis in adults, e.g. forms that quickly lead to the destruction of the joint:
12-16 mg (3-4 tablets), when extra-articular tissue is affected: 6-12 mg (1½ - 3 tablets).

Juvenile idiopathic arthritis in children:
12-16 mg/day (3-4 tablets).

Rheumatic fever with inflammation of the heart:
12-16 mg/day (3-4 tablets).

Severe infectious diseases with poisoning-like conditions:
4-20 mg/day (1-5 tablets) for several days, only as an addition to the relevant anti-infective therapy.

Supportive treatment for malignant tumors:
Initially 8-16 mg/day (2-4 tablets), with long-term treatment 4-12 mg/day (1-3 tablets).
Prevention and treatment of emesis from cytostatic therapy as part of an antiemetic regimen:
10-20 mg (2 ½-5 tablets) before the start of chemotherapy, then 4-8 mg (1-2 tablets) 2-3 times a day if necessary for 1-3 days or up to 6 days.

Take this medicine exactly as prescribed by your doctor. Your doctor will decide how long to take dexamethasone. If you are not sure, ask your doctor or pharmacist.

Dexamethasone Teva 4 mg tablets for the treatment of Covid-19
It is recommended that adult patients take 6 mg (1 1/2 tablets) once daily for up to 10 days.

Use in adolescents
Pediatric patients (aged 12 years or older): it is recommended to take 6 mg (1 1/2 tablets) once daily for up to 10 days.

Application method
Tablets for oral administration.
The tablets are taken whole with a large amount of liquid during or after a meal. Whenever possible, the daily dose should be taken as a single dose in the morning. However, for diseases that require high-dose therapy, multiple doses throughout the day are often required to obtain maximum effect.

Duration of treatment
The duration of treatment depends on the underlying disease and the course of the disease. Your doctor will prescribe a therapeutic regimen that must be carefully followed. When satisfactory treatment results are achieved, the dose will be reduced to the maintenance dose level or the treatment will be stopped. The dose should be gradually reduced.

In case of reduced thyroid function or cirrhosis of the liver, administration of lower doses may be sufficient or a dose reduction may be necessary.

If you have taken more than the required dose of Dexamethasone Teva
Even if taken for a short time in large amounts, dexamethasone is usually well tolerated without complications. No special measures are required. If you notice an increase in side effects or they are unusual, tell your doctor.

If you forget to take Dexamethasone Teva
You can take the missed dose during the day and then continue with the prescribed dose the next day as usual. Do not take a double dose to make up for a missed dose.

If several doses are missed, this may lead to relapse or worsening of the disease being treated. In such cases, you should consult your doctor, who will review the treatment and adjust it if necessary.

If you stop taking Dexamethasone Teva
Always follow the dosage regimen prescribed by the doctor. Taking dexamethasone should not be stopped without permission, especially because long-term treatment can lead to a decrease in the body's production of glucocorticoids (insufficiency of the adrenal cortex). High-stress physical situations without adequate glucocorticoid production can prove fatal.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Infections and infestations:
Masking of infections, onset and worsening of viral, fungal, bacterial infections, as well as parasitic or opportunistic infections, activation of roundworm infections.

Blood and lymphatic system disorders:
Changes in the blood count (increased number of white blood cells or all blood cells, decreased number of some white blood cells).

Disorders of the immune system:
Hypersensitivity reactions (eg drug rash), severe anaphylactic reactions such as heart rhythm disturbances, bronchospasm (bronchial smooth muscle spasm), increased or decreased blood pressure, circulatory collapse, cardiac arrest, weakening of the immune system.

Endocrine disorders:
Manifestation of Cushing's syndrome (typical signs include a round face, obese abdomen and flushing), insufficiency or lack of activity of the adrenal cortex.

Metabolism and nutrition disorders:
Increased weight, increased blood sugar, diabetes, increased blood lipids (cholesterol and triglycerides), increased sodium levels and swelling (oedema), potassium deficiency due to increased potassium excretion (may lead to heart rhythm disorders) , increased appetite.

Mental disorders:
Depression, irritability, euphoria, increased libido, psychoses, mania, hallucinations, mood swings, anxiety, sleep disorders, suicidal tendencies.

Disorders of the nervous system:
Increased intracranial pressure, manifestation of previously unrecognized epilepsy, more frequent convulsions in already established epilepsy.

Eye disorders:
Increased intraocular pressure (glaucoma), clouding of the lens (cataract), worsening of corneal ulcers, increased manifestations or worsening of eye inflammation caused by viruses, bacteria or fungi; worsening non-bacterial inflammation of the cornea, drooping eyelid, dilated pupils, swelling of the conjunctiva, perforation
5. How to store Dexamethasone Teva
To be stored in a place inaccessible to children.

Do not use this medicine after the expiry date which is stated on the carton or bottle label after EXP. The expiry date corresponds to the last day of the month stated.

To be stored below 30°C

To be stored in the original packaging.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Dexamethasone Teva contains
Active substance: dexamethasone. Each tablet contains 4 mg of dexamethasone.
Other ingredients: corn starch, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
What Dexamethasone Teva looks like and contents of the pack
Yellowish-white, round tablets scored with a cross on one side.

 

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