Afobam – indications, contraindications, dosage and side effects

Proven content

Afobam is a drug that is typically used in psychiatric treatment. It is a prescription-only preparation. It works primarily to induce sleep, relieve anxiety and have a calming effect. Your doctor may prescribe Afobam when you are diagnosed with anxiety or depression. How does Afobam work and what substances does it contain? When is the use of the drug contraindicated? What precautions should be taken while taking the drug? How do I dose Afobam correctly? Is it worth reaching for its substitutes?

Afobam – general characteristics of the drug

Afobam is a prescription drug that has anxiolytic, hypnotic, anticonvulsant and sedative effects. It is used primarily in psychiatric treatment, especially in the diagnosis of generalized or panic disorder in a patient, as well as in the case of neurotic depression and anxiety syndromes. The active substance in Afobam is alprazolam.

The drug is available in the form of tablets in three doses of the active ingredient: 0,25 mg, 0,5 mg and 1 mg. Afobam is a white or yellowish-white tablet which does not have any odor. They are oblong, convex on both sides. The tablets have a dose score line, and an “E” on one side and “311” on the other side. The groove makes it easy to divide the tablet in half.

Afobam can be purchased in two different packages. The first is a brown glass bottle with a polyethylene screw cap with a secure closure, in a cardboard box. In such a bottle there are 30 or 100 tablets. Afobam can also be purchased in PVC / PE / PVdC blisters in a cardboard box. This package contains 30 tablets (2 blisters of 15 tablets each).

The pharmaceutical company EGIS is the producer and entity responsible for the distribution of Afobam on the Polish market. The products of this concern are available in 60 countries, and the offer of the EGIS company includes almost 620 products. The activities of the EGIS company focus on the treatment of cardiovascular and nervous system diseases. The origins of the EGIS company date back to 1913, when the Hungarian pharmacist Dr. Sándor Balla and the owner of the Swiss pharmaceutical company, Dr. Albert Wander, registered the company under the name “Dr. Wander Pharmaceuticals and Nutriments Ltd ”. The new headquarters of the company, which still houses the EGIS headquarters, were built in a few months on Keresztúri Street in Budapest, and the production of drugs began in 1914.

What is worth knowing about the structure and functions of the nervous system? Check: Nervous system – structure and ailments

Afobam – composition and action of the drug

The active substance of Afobam is alprazolam, i.e. an organic chemical compound – a triazole derivative of benzodiazepine (BZD) with an intermediate duration of action. This compound exhibits fast, strong and short-term anxiolytic, sedative, muscle-relaxing, anticonvulsant and amnestic effects.

The active substance works by attaching to a benzodiazepine receptor, causing a specific reaction in the cell. Benzodiazepine receptors are part of receptors known as GABA-A receptors and have the ability to bind many substances. Alprazolam works indirectly by increasing the ability of GABA to bind to the GABA-A receptor. Given the inhibitory effect of GABA on the activity of nerve cells, benzodiazepines exert an indirect inhibitory effect on the central nervous system.

The active substance of the drug has an anxiolytic, hypnotic, sedative, anticonvulsant effect and also reduces muscle tension. Compared to other benzodiazepines, alprazolam has a stronger anxiolytic and anxiolytic effect while maintaining muscle relaxant, anticonvulsant and sedative-hypnotic effects.

1 tablet of Afobam contains 0,25 mg, 0,5 mg or 1 mg of alprazolam, respectively. The other ingredients of the preparation are: lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, sodium lauryl sulfate and colloidal anhydrous silica. In addition, 0,5 mg tablets contain yellow iron oxide, and 1 mg tablets – red iron oxide.

How do anti-anxiety drugs work and when should you take them? Check: Anti-anxiety drugs – types, action, natural preparations. How are anxiety disorders treated?

Afobam – metabolism and absorption

The active substance of the drug Afobam after oral administration is well and quickly absorbed. The maximum serum concentration is approximately 0,7–2,1 hours after taking the drug or 5–11 hours in the case of the prolonged-release tablet. The biological half-life is 10-16 hours, and may be prolonged in elderly, obese or cirrhotic patients.

Alprazolam is metabolized in the liver, incl. to the active – hydroxyalprazolam. Alprazolam and its metabolites are excreted 80% in the urine and 7% in the faeces.

Why are drugs bad for the liver? Check: Drugs dangerous to the liver

Afobam – indications for use

Afobam is a drug used in psychiatry. The indications for the use of Afobam are:

1. treatment of generalized anxiety disorder;
2. treating anxiety disorder with anxiety attacks (with or without agoraphobia);
3. treating phobic anxiety disorder;
4. treatment of depressive disorder and mixed anxiety disorder.

It is important to remember that taking Afobam is only recommended in situations where the patient’s symptoms are very severe, thus impairing normal functioning and causing inconvenience in daily activities.

How to recognize anxiety disorders, especially during a pandemic? Check: How is an anxiety disorder diagnosed during a pandemic?

Afobam – contraindications to use

The drug Afobam, despite its effectiveness, cannot be used by all patients who struggle with anxiety or depressive disorders. The manufacturer of the drug clearly indicates when Afobam should not be used. Contraindications to the use of Afobam are:

1. allergy to the active substance or any of the excipients;
2. muscle weakness;
3. severe respiratory failure;
4. night apnea syndrome;
5. severe liver failure;
6. age of the patient – the drug should not be used in patients under 18 years of age.

What should you know about anxiety disorders? Read: Anxiety disorders – causes, symptoms. Are anxiety disorders curable?

Afobam – precautions

Before and during the use of Afobam, follow the precautions included in the package leaflet.

The precautionary measures include:

1. drug tolerance – tolerance or the need to increase the dose of Afobam is rare with alprazolam, but it is possible. Tolerance was shown to be a sedative effect of alprazolam but not an anxiolytic effect;
2. the possibility of becoming addicted to the preparation – dependence and emotional or physical dependence may develop while taking Afobam. Particular care should be taken when prescribing benzodiazepines to patients prone to drug (including drug) and alcohol abuse, as these patients are particularly predisposed to the development of addiction;
3. the occurrence of withdrawal symptoms – reducing the dose of Afobam or abrupt discontinuation of the preparation may lead to rebound or withdrawal symptoms. The dose reduction should be gradual, especially in patients with epilepsy;
4. increased risk of suicidal behavior and suicide – if the drug is administered to patients with depression or suicidal tendencies, appropriate precautions should be taken, and the drug itself should be prescribed in the appropriate dose and quantity. An association has been shown between panic disorder and depression in untreated patients, and an increased number of suicides; 
5. duration of treatment – usually benzodiazepines, including Afobam, are given for a short time. However, there are cases where the patient’s health condition requires long-term use of the preparation. In such a situation, the attending physician should periodically verify whether the patient requires further treatment with this drug. Using Afobam for too long can lead to psychological dependence;
6. oblivion – the use of Afobam may induce anterograde amnesia in the patient. Symptoms of amnesia usually occur a few hours after taking the preparation;
7. mental and paradoxical reactions – while taking Afobam, the patient may experience a paradoxical reaction manifested by restlessness, psychomotor agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, inappropriate behavior or other disorders.
8. special groups of patients – in some cases, special precautions should be taken. This applies to patients with angle-closure glaucoma, the elderly, or patients with renal or hepatic impairment;
9. interaction with other preparations – if the patient is taking alprazolam together with other sleeping pills or sedatives, or if you consume alcohol during the treatment, an additive effect of these substances may occur;
10. lactose in the composition of the drug – Afobam contains lactose, therefore it should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

You should also remember to store Afobam at a temperature below 25 degrees Celsius, out of the reach of children. Expired medications should not be used. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Afobam – drug dosage

Afobam should always be used as described in the leaflet or as directed by your doctor or pharmacist. Always consult a doctor if you have any doubts.

The correct dose of the drug depends on the condition the patient is struggling with:

1. generalized anxiety disorder; and anxiety syndrome with secondary depressed mood — an initial dose of 0,25-0,5 mg of the drug is recommended given to the patient three times a day. At the start of treatment, the patient is given the lowest effective dose, and the dose is increased further depending on the severity of the symptoms. The doses should always be selected individually according to the severity of symptoms, and the dose should be increased gradually, starting with increasing the evening dose. The dose may be increased to 3 mg daily, which will be administered in divided doses. Maximum daily dose for the treatment of severe anxiety, it is 4 mg. The daily dose maintaining the effects of treatment is, however, from 0,5 to 3 mg given in divided doses;
2. panic disorder with or without agoraphobia — the recommended starting dose is 0,5 mg and is given three times a day. The dose may be increased by 0,5 mg every 3 to 4 days to achieve adequate treatment results. The increase in side effects of the drug should also be taken into account. 
3. anxiety attacks — the recommended dose is 5 mg to 6 mg alprazolam per day; the maximum daily dose is 10 mg (given in 3 or 4 divided doses). 

In the case of elderly patients and those struggling with debilitating diseases, the initial dose should not exceed 0,25 mg two or three times a day. If necessary, the dose can be gradually increased, while monitoring the patient’s response and tolerance to the drug taken. If any side effects begin, the starting dose should be reduced.

Treatment of the patient with Afobam should be as short as possible. It is the duty of the physician to regularly assess the patient’s condition and make decisions about the need to continue treatment. It is estimated that the use of Afobam should not exceed 8-12 weeks.

It is worth mentioning that patients who have not previously been treated with psychotropic drugs require lower doses than those who have previously taken sedatives, antidepressants or sleeping pills.

Stopping treatment with Afobam should be gradual. The dose should be reduced by no more than 0,5 mg every three days. In some cases, dose reduction should be made even more slowly.

What are psychotropic drugs and how do they work? Read: Psychotropic drugs – what should you know before using them?

Afobam – drug overdose

Despite the low toxicity of the active ingredient in Afobam, data from the American Substance Abuse and Mental Health Services Administration indicate that this compound is the most commonly used benzodiazepine in overdoses that require hospitalization.

Overdose of the drug Afobam It manifests itself as ataxia, somnolence, speech disorders, coma or respiratory depression. An overdose of Afobam is very rarely a life-threatening condition, but in combination with alcohol or barbiturates, it can be a dangerous and toxic mixture for human health and life.

Treatment of overdose with Afobam is to support breathing and circulation. In the case of coma, treatment is symptomatic, including the prevention of complications such as asphyxia due to tongue collapse or gastric aspiration. In order to prevent dehydration, patients will receive intravenous fluids following overdose.

If the patient is taking Afobam and other sleeping pills at the same time, it is essential to maintain vital functions in the case of medical assistance. Gastric lavage and / or administration of activated charcoal is indicated when a short time has elapsed since taking the drug. An osmotic laxative may then be administered.

If an overdose leads to severe intoxication with coma or respiratory failure, the patient is administered intravenous flumazenil as an antidote.

What are the symptoms of neuroleptic poisoning? Check: Poisoning with neuroleptic drugs

Afobam – side effects

The drug Afobam, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The following side effects may occur when taking Afobam.

Very common side effects after taking Afobam (more than 1 in 10 patients):

1. depression;
2. satisfaction;
3. somnolence;
4. ataxia (clumsiness);
5. memory impairment;
6. speech disorders;
7. dizziness;
8. Headache;
9. constipation;
10. dry mouth;
11. tiredness;
12. irritability.

Common side effects after taking Afobam (1 in 10-100 patients):

1. decreased appetite;
2. entanglement;
3. confusion;
4. decreased sex drive;
5. increased sex drive;
6. bow;
7. insomnia;
8. nervousness;
9. balance problems;
10. movement coordination disorders;
11. concentration disorders;
12. increased drowsiness;
13. letarg;
14. trembling;
15. blurred vision;
16. nausea;
17. skin infection;
18. sexual dysfunction;
19. weight loss;
20. weight gain.

Uncommon side effects after taking Afobam (1 in 100-1000 patients):

1. mania;
2. hallucinations;
3. anger;
4. stimulation;
5. addiction;
6. amnesia;
7. muscle weakness;
8. urinary incontinence;
9. irregular menstruation;
10. drug withdrawal syndrome;

The frequency of side effects after the use of Afobam is unknown:

1. hyperprolactinaemia (increased blood prolactin levels);
2. hypomania;
3. aggressive behavior;
4. hostile behavior;
5. disturbed thinking;
6. increased psychomotor activity;
7. drug abuse;
8. imbalance of the autonomic nervous system (which directs the functioning of internal organs, smooth muscles and glands);
9. dystonia (disorders of muscle tone);
10. gastrointestinal disorders;
11. hepatitis;
12. liver dysfunction;
13. jaundice;
14. angioedema;
15. photosensitivity reactions;
16. urinary retention;
17. peripheral edema (swelling of the ankles, feet or fingers);
18. increased intraocular pressure.

Afobam – drug interactions

Before taking Afobam, tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about any drugs you plan to take.

Afobam cannot be used with other psychotropic drugs, anticonvulsants or antihistamines because the active substance of the drug interacts with these drugs and has an additive depressive effect on the central nervous system.

Previous studies have shown that special care should be taken when using:

1. Central nervous system depressants. These are painkillers, antiepileptics, neuroleptics, hypnotics, sedatives, antidepressants, antihistamines with a sedative effect. Their effects may be increased when used together with Afobam; 
2. benzodiazepines and opioids – your doctor will likely reduce your dose by at least a third and then slowly increase it;
3. imipramines and desipramines – their plasma concentration may increase;
4. substances that inhibit certain liver enzymes – they can increase the concentration of alprazolam and potentiate its effects;
5. HIV protease inhibitors (e.g. ritonavir) – your doctor will probably recommend a dose adjustment or discontinuation of alprazolam;
6. nefazodone, fluvoxamine, and cimetidine – your doctor may decide to reduce the doses accordingly;
7. fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, or macrolide antibiotics such as erythromycin and troleandomycin;
8. ketoconazole, itraconazole and other azole antifungal drugs;
9. teofiliny – antagonizes the effect of drugs from this group.

Which drugs should never be combined with each other? Check: Dangerous interactions

Afobam and pregnancy and breastfeeding

During pregnancy and breastfeeding, do not take any medications without first consulting your doctor. Afobam is not recommended for pregnant women. If a patient’s condition requires treatment during the last trimester of pregnancy, the newborn may develop a variety of symptoms such as hypothermia, hypotension, and respiratory depression. Physical dependence is possible in the newborn born to mothers treated with alprazolam, and withdrawal symptoms may occur as the drug is eliminated after birth.

Alprazolam passes into breast milk. Sleepiness and weight loss in infants have been reported as a consequence of administration to nursing mothers. Therefore, this medicine should not be used during breastfeeding.

How often do pregnant women have a mental health problem? Check: One in four pregnant women has mental health problems

Afobam – the price

The price of the drug Afobam may differ depending on the town where the preparation will be purchased or the selected pharmacy. The price of the preparation also depends on the amount of active substance in the tablet and the size of the package:

1. Afobam 30 tablets 0,25 mg – approx. PLN 15;
2. Afobam 30 tablets of 0,5 mg – about PLN 23;
3. Afobam 30 tablets of 1 mg – about PLN 32.

Do you know what is trypophobia? Check: Trypophobia – fear of holes

Afobam – drug substitutes

Products that have the same international name and exist in the same form do not have to be substitutes, because the use of a given drug is determined by the content of the active substance, i.e. the dose of the drug.

It should be remembered that even when the dose of the active substance is similar, the patient may not always use the substitute, because he may be allergic to any of the other excipients of the drug.

Therefore, before using a substitute for Afobam, read the package leaflet or consult your doctor or pharmacist.

The drugs containing alprazolam include:

1. Alpragen in tablets;
2. Alprazolum Aurovitas in tablets;
3. Alprox in tablets;
4. 0,25 neurol in tablets;
5. 1,0 neurol in tablets;
6. Neurol SR 0,5 in tablets with prolonged action;
7. Xanax in tablets;
8. Xanax SR in tablets with prolonged action;
9. Zomiren in tablets;
10. Zomiren SR in tablets of prolonged action.

When is it worth reaching for a replacement for a prescription drug? Check: Swap when you can