Lorafen – composition, action, dosage and side effects

Proven content

Lorafen is a preparation showing hypnotic, sedative, anxiolytic, anticonvulsant and muscle relaxing properties. This drug is available in stationary pharmacies upon presentation of a valid prescription. The active substance in Lorafen is lorazepam, a benzodiazepine. What are the indications and contraindications for the use of Lorafen? How to correctly dose this drug and how to use it? Can taking Lorafen cause side effects in a patient? How much does a pack of this drug cost?

Lorafen – general characteristics of the drug

Lorafen is a prescription-only medicine with the active ingredient lorazepam. This preparation is primarily anxiolytic and hypnotic. It also shows a weaker anticonvulsant effect and relaxes the tension of skeletal muscles.

Lorafen is available in the form of coated tablets:

1. 1 mg tablets they are white, round, biconvex and smooth;
2. 2,5 mg tablets they are pink, round, biconvex and smooth.

One package contains 25 sugar-coated tablets.

The entity responsible for the production and distribution of Lorafen is Tarchomińskie Zakłady Farmaceutyczne “Polfa” Spółka Akcyjna. Polfa Tarchomin is a Polish pharmaceutical company with its seat in Warsaw. The origins of this company date back to 1823. The Chemical Products Factory was established at that time, later transformed into Przemysłowo-Handlowe Zakłady Chemiczne “Ludwik Spiess i Syn. Polfa Tarchomin was one of the first insulin producers in the world, but also the only producer of penicillin. The company is one of the largest producers of generic drugs in Poland. It produces, among others anti-infective drugs, insulins, psychotropic drugs and dermatological preparations.

In addition, the distribution of this drug may be responsible for:

1. InPharm Sp. z o. o. – InPharm is a company that has been dealing with parallel import and distribution of medicinal products, medical devices and cosmetics since 2006. The company has an extensive network of suppliers throughout the European Union. The company’s headquarters is located in Warsaw;
2. Delfarma Sp. z o. o. – Delfarma is a leader in parallel import. This company supplies the Polish market with cheaper drugs and thus significantly contributes to the reduction of health care costs. The Delfarma company was established in 2004 and offers over 500 drugs. The company’s head office is located in Łódź;
3. Forfarm Sp. z o. o. – direct parallel importer. The company has over 400 licenses for pharmaceutical products. The company Forfarm Sp. z o. o. started its commercial activity in 2006. It is primarily a pharmaceutical wholesaler with an established position on the pharmaceutical market. The main activity of the company is trade in medicinal products under the parallel import procedure and export to licensed entities in the European Union countries. The company’s headquarters is located in Warsaw.

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Lorafen – composition and action of the drug

Lorafen is a hypnotic and anxiolytic. Its active substance, i.e. lorazepam, is responsible for this action of this preparation. One tablet of Lorafen may contain 1 mg or 2,5 mg of lorazepam.

Lorazepam is a benzodiazepine derivative and has an intermediate duration of action. This compound binds to the benzodiazepine receptor, which influences a specific reaction in the cell. This means that lorazepam is an antagonist. Benzodiazepine receptors are part of the receptors known as GABA-A receptors, which are able to bind many substances, including aminobutyric acid (GABA). Lorazepam acts indirectly by increasing the ability of GABA to bind to the GABA-A receptor. Due to the inhibitory effect of GABA on nerve cells, benzodiazepines exert an indirect inhibitory effect on the central nervous system.

Therefore, lorazepam has an anxiolytic, hypnotic, sedative, anticonvulsant and muscle relaxant effect.

Lorazepam is well absorbed from the gastrointestinal tract after oral administration. The maximum serum concentration is reached 1-2 hours after administration. Bioavailability is 90%. Lorazepam is metabolised in the liver to inactive derivatives. The drug is eliminated slowly through the kidneys.

The other excipients of Lorafen are:

1. potato starch;
2. sodium carboxymethyl starch (type A);
3. gelatine;
4. talk;
5. magnesium stearate;
6. lactose jednowodna;
7. polyvinyl alcohol;
8. maltodextrin;
9. sucrose;
10. titanium dioxide;
11. Opaglos 6000.

In addition, the 2,5 mg tablets, due to their pink color, contain a coloring component, cochineal red (E-124).

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Lorafen – indications for use

Lorafen is a preparation that is used primarily in cases of sleep problems caused by anxiety. Your doctor may recommend this medication, especially for the treatment of:

1. anxiety of various origins, accompanying cardiovascular or gastrointestinal diseases; 
2. sleep disturbance associated with states of increased anxiety.

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Lorafen – contraindications to use

The drug Lorafen, despite its effectiveness in combating anxiety and sleep problems, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Lorafen are:

1. allergic to lorazepam or other drugs from the benzodiazepine group, or any of the ingredients of the drug;
2. severe respiratory failure;
3. frequent, short pauses in breathing during sleep;
4. severe liver and kidney failure;
5. narrow-angle glaucoma;
6. myasthenia;
7. porphyria oyster;
8. poisoning with alcohol or drugs that act on the central nervous system;
9. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
10. rare inherited disorders of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

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Lorafen – precautions

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

Precautions to keep in mind while taking Lorafen include:

1. drug tolerance – after taking Lorafen for several weeks, its effectiveness may decrease;
2. drug addiction – the use of lorazepam for a long time may lead to mental and physical dependence. The risk of developing dependence increases with increasing dose and duration of treatment, and is greater in patients with alcohol or drug dependence, and in patients with personality disorders;
3. the occurrence of withdrawal symptoms – if you stop taking the drug suddenly, you may experience withdrawal symptoms such as headache, muscle aches, increased anxiety, tension, excitement, restlessness, confusion, sleep disturbances, irritability. In more severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, tingling sensation and numbness in the limbs, hallucinations and delusions, epileptic seizures;
4. the occurrence of the “rebound” phenomenon – when you stop taking Lorafen, you may experience a temporary flare-up of the severe symptoms that were behind the medicine, the so-called rebound phenomenon. These symptoms are often accompanied by mood changes, anxiety, sleep disturbance and insomnia. In order to minimize the risk of these symptoms, it is recommended to gradually reduce the dose of the drug;
5. the occurrence of subsequent amnesia – Lorafen can cause anterograde amnesia, that is, it is difficult to learn and remember new information – new data is not permanently remembered. This condition occurs most often within a few hours of drug administration, especially in high doses. If your doctor has prescribed Lorafen once a day, in order to reduce the risk of anterograde amnesia, it is recommended to take the drug half an hour before going to bed and to ensure adequate conditions for a continuous, uninterrupted sleep of 7-8 hours;
6. mental and paradoxical reactions – children and the elderly are at increased risk of developing abnormal mental and paradoxical reactions (contrary to the expected ones), such as: restlessness, agitation, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychosis, behavioral disorders . 

It is also worth paying attention to the precautions that must be taken in the case of certain groups of patients:

1. Elderly patients should receive lower doses of Lorafen because of the possible increase in side effects, mainly disorientation and coordination disorders (falls, injuries);
2. patients with liver or kidney failure or chronic respiratory failure should inform their doctor about their condition before taking Lorafen;
3. patients with symptoms of depression or anxiety related to depression should take several medications at the same time. Giving depressed patients only Lorafen may worsen symptoms of depression, including thoughts of suicide. Masked depression may become apparent with benzodiazepines;
4. patients who are addicted to alcohol, drugs or medications should inform their doctor about these addictions before taking Lorafen, as they are at high risk of developing psychological and physical dependence. This group of patients should use Lorafen under close medical supervision;
5. patients with glaucoma, before starting treatment with Lorafen, should inform their doctor about this disease;
6. Lorafen in patients with porphyria may make the symptoms of this disease worse. Patients with porphyria should inform their doctor about this disease before starting treatment with Lorafen.

It is worth remembering that during prolonged treatment with lorazepam, your doctor will usually order periodic blood tests (complete blood counts with smear) and urinalysis.

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Lorafen – dosage and method of use

Always use Lorafen exactly as described in the package leaflet or as directed by your doctor or pharmacist.

For the treatment of anxiety disorders The initial dose of Lorafen for adults and children over 12 years of age is 2 to 3 mg of lorazepam daily. This dose is divided into 2 or 3 parts administered throughout the day. If necessary, the doctor may increase the dose to 6 mg a day, also given in 2 or 3 divided doses.

Lorazepam dose titration is gradual and starts with increasing the evening dose. The maximum dose of the drug is 10 mg daily.

For the treatment of sleep disorders, the patient is usually given 2 to 4 mg of lorazepam once a day just before going to bed.

Lorafen tablets should be swallowed with a little water. Your doctor will start treatment with the lowest effective dose and will gradually increase it as necessary.

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Lorafen – misuse of the drug

Inappropriate use of Lorafen is considered to be taking more than the recommended dose of the drug or missing the indicated dose during the day.

Symptoms of an overdose of Lorafen there are disturbances of consciousness, drowsiness, slurred speech. In severe cases of poisoning, ataxia, hypotension, muscle weakness, respiratory distress, coma and even death may occur.

If you use more Lorafen than you should, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine with you in the original carton so that the staff can check exactly which medicine has been used.

If, on the other hand, you forget to take a dose, take the next dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next one as prescribed. If you forget to take two or more doses, contact your doctor. Do not use a double dose to make up for a forgotten dose.

Also, do not stop taking the medicine unless you are told to do so by your doctor. It is possible for symptoms to recur. If the doctor decides to stop using the drug, the dose of the drug should be gradually reduced over a period of several days.

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Lorafen – side effects

Lorafen, 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).

When describing the side effects that may occur with Lorafen, consideration should be given to their severity.

Rare severe side effects:

1. confusion, states of excitement and agitation, depression;
2. Yellow skin, the whites of the eyes, and brown urine – these may be symptoms of jaundice.

Very rare serious side effects:

1. severe allergic reaction such as itching, swelling of the lips or tongue or wheezing or shortness of breath;

Serious side effects with a frequency not known:

1. depression with suicidal tendencies, restlessness, irritability, delusions, nightmares, hallucinations (seeing or hearing things that are not there), psychosis (loss of contact with reality), unusual behavior. These disorders most often appear after the consumption of alcohol and the elderly or those with mental illnesses;
2. coma.

If you experience any of the side effects listed above while taking Lorafen, inform your doctor immediately or go to the nearest hospital emergency department.

Other side effects that may occur with Lorafen are classified according to how often they occur.

Very common (affects more than 1 in 10 people):

1. somnolence;
2. slowing down the reaction.

Common (affects less than 1 in 10 people):

1. muscle weakness.

Rare (affects less than 1 in 1 people):

1. rashes, itching, hives;
2. confusion;
3. emotional disorders;
4. lack of self-control;
5. impulsiveness;
6. euphoria;
7. sleep disturbance;
8. disclosure of pre-existing but undiagnosed depression;
9. headache and dizziness;
10. disturbance of consciousness and confusion;
11. incoherence of movements;
12. visual disturbances (blurred, double vision);
13. a slight decrease in blood pressure;
14. nausea, stomach discomfort;
15. feeling of dry mouth;
16. slight elevation of liver enzymes;
17. hepatic dysfunction, with the onset of jaundice.

Very rare (affects less than 1 in 10 people):

1. change in the number of certain blood cells;
2. trembling around the mouth;
3. rhythmic tremors of the fingers;
4. uncontrolled movements;
5. twisting the head, torso, face.

Not known:

1. lack of appetite;
2. paradoxical reactions: psychomotor restlessness, insomnia, increased excitability and aggressiveness, muscle tremors, convulsions;
3. mental and physical addiction;
4. feeling sleepy;
5. dizziness;
6. slowing down the reaction;
7. somnolence;
8. memory impairment;
9. motor coordination disorders;
10. speech disorders;
11. changes in sex drive;
12. slow heart rate;
13. pain in the chest;
14. urinary retention, urinary incontinence;
15. menstrual disorders, sex drive;
16. general weakness, fainting.

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Lorafen – interactions with other drugs

Before starting treatment with Lorafen, please inform your doctor or pharmacist about all the medicines you are taking or have taken recently. You should also inform what medications the patient plans to take in the near future.

Medicines that Lorafen may interact with include:

1. fluvoxamine, fluoxetine and other drugs used to treat mental illness;
2. drugs for the treatment of insomnia;
3. medicines for allergic diseases that can cause drowsiness;
4. epilepsy medicines – e.g. carbamazepine, phenytoin, hydantoin;
5. drugs used in gastric and duodenal ulcers – e.g. cimetidine, omeprazole, cisapride;
6. rifampicin – a drug used to treat tuberculosis;
7. ketoconazole – an antifungal drug;
8. drugs used for general anesthesia;
9. strong painkillers, e.g. morphine, codeine – narcotic painkillers used simultaneously with lorazepam may increase euphoria, which may lead to faster psychological dependence;
10. skeletal muscle relaxants – e.g. Baclofen;
11. medicines for Parkinson’s disease – e.g. levodopa;
12. oral contraceptives – can reduce the effect of lorazepam;
13. opioids: concomitant use of Lorafen and opioids increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be life-threatening. Therefore, concomitant use of these drugs should only be considered when other treatment options are not possible;
14. alcohol – it may increase the effect of the drug and lead to paradoxical reactions, such as: psychomotor agitation, aggressive behavior.

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Lorafen and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Lorafen

The use of the drug in pregnant women is contraindicated, especially in the first and third trimesters.

The use of lorazepam in the last trimester or the perinatal period in the newborn may cause:

1. lowering body temperature, pressure;
2. Heart arythmia;
3. breathing disorders in the fetus and newborn;
4. weakening of the sucking reflex.

The babies of mothers taking benzodiazepines chronically in late pregnancy develop physical dependence and are at risk of developing withdrawal symptoms after birth.

The drug should not be used by breastfeeding women as it passes into breast milk. If it is necessary to administer the drug to the mother, breast-feeding should be discontinued.

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Lorafen — cena

The price of the drug Lorafen may differ depending on the city in which the preparation will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the content of the active substance in the tablet:

1. 1 mg sugar-coated tablets cost about PLN 23;
2. 2,5 mg coated tablets cost about PLN 25.

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Lorafen – 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 Lorafen, read the package leaflet or consult your doctor or pharmacist.

The Lorabex preparation, produced by Polpharma, may be a substitute for Lorafen. 25 tablets of 1 mg cost about PLN 16, while 25 tablets of 2,5 mg cost about PLN 17-18.

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