Dexamethasone Kern Pharma 4 mg/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dexamethasone Kern Pharma 4 mg/ml injection solution EFG

Dexamethasone phosphate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dexamethasone Kern Pharma is and what it is used for.
2. What you need to know before using Dexamethasone Kern Pharma.
3. How to use Dexamethasone Kern Pharma.
4. Possible side effects.
5. How to store Dexamethasone Kern Pharma.
6. Package contents and additional information.

1. What Dexamethasone Kern Pharma is and what it is used for

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) with high anti-inflammatory and immunosuppressive activity and minimal mineralocorticoid effect.

By intramuscular or intravenous route, it is indicated in the treatment of:

• Acute and chronic inflammatory processes of various causes and localizations.
• Endocrine disorders.
• Hypercalcemia associated with cancer and congenital adrenal hyperplasia.
• Severe allergic conditions.
• Severe acute and chronic inflammatory and allergic processes affecting the eyes.
• Systemic treatment during critical periods of ulcerative colitis and regional enteritis.
• Skin diseases, respiratory diseases, and blood disorders.
• Idiopathic (non-uremic) nephrotic syndrome or that caused by systemic lupus erythematosus (an autoimmune disease).
• Cerebral edema associated with brain tumor, craniotomy, or head injury.

It is also indicated as:

• Short-term adjunctive treatment during acute episodes or exacerbations of rheumatic diseases.
• During an exacerbation or as maintenance therapy in some cases of systemic lupus erythematosus and acute rheumatic carditis.
• For palliative treatment of leukemias and lymphomas in adults and of acute leukemias in children.

By intravenous route:

• This medicine is used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (from 12 years of age with a body weight of at least 40 kg) who require supplemental oxygen therapy.

By intra-articular, intralesional, or soft tissue injection, it is indicated for:

• Short-term adjunctive therapy in acute episodes or exacerbations of rheumatic diseases.
• Intralesional injection in inflammatory processes.

2. What you need to know before starting to use Dexamethasone Kern Pharma

Do not use Dexamethasone Kern Pharma

• If you are allergic or have had an allergic reaction to the active substance in this medicine, any of its components, or to any other medicine. These reactions are more common in patients with a previous history of drug allergy.
• If you have fungal infections, tuberculosis or parasitic infections, herpes, measles, or chickenpox, unless you are receiving appropriate chemotherapeutic treatment and are under close medical supervision.
• For prolonged treatments, if you have congestive heart disease, myasthenia gravis (muscle weakness), peptic ulcer or esophagitis (inflammation of the esophagus), diabetes, or ocular herpes simplex.
• If you need to be vaccinated.

Warnings and precautions

• If you suffer from inflammatory diseases of the digestive system, kidney insufficiency, hypertension, osteoporosis, or myasthenia gravis (muscle weakness).
• With high doses, fat embolism (accumulation of fat) may occur.
• Exposure to the varicella and measles viruses should be avoided.
• During chronic treatment in children, due to the risk of adrenal suppression and growth retardation.
• During treatment in elderly patients, as cases of osteoporosis, fluid retention, and increased blood pressure may occur.
• Concomitant administration of antibiotics and corticosteroids should be monitored, as it may lead to dissemination of infection if the causative microorganism is not sensitive to the antibiotic used.
• When treating with corticosteroids, always use the lowest possible dose needed to control the pathological condition.
• In patients with hypothyroidism or cirrhosis, corticosteroids may have an enhanced pharmacological effect.
• Intra-articular administration of a corticosteroid by injection may produce systemic and local effects.
• Injection of a corticosteroid into an infected site must be avoided. They should also not be injected into unstable joints. Frequent intra-articular injections may cause damage to joint tissues.
• Inform your doctor if you experience any of the following symptoms: Symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, loss or changes in vision, and difficulty breathing, especially if you have a malignant hematological disorder.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If dexamethasone is administered to a premature infant, cardiac function and structure must be monitored.

Use of Dexamethasone Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of some of them. Note that these instructions may also apply to medicines used previously or that may be used in the future.

This is especially important if you are taking the following medicines:

• Antiepileptics (phenobarbital and carbamazepine), antiarrhythmics (phenytoin), antiasthmatics and bronchodilators (adrenaline and ephedrine), antituberculosis antibiotics (rifampicin), and anticancer drugs (aminoglutethimide) may reduce the therapeutic effect of dexamethasone.
• Estrogens may increase the effect of dexamethasone.
• Increased therapeutic effect of salicylates and antihelminthics (albendazole).
• It may reduce the effects of antidiabetic agents.
• When used with medicines for heart conditions (cardiac glycosides and potassium-depleting diuretics), it may cause decreased potassium levels and increased cardiac toxicity.
• With prostaglandin synthesis inhibitors (indomethacin), mutual potentiation of toxicity may occur.
• Reduced plasma levels of certain antituberculosis drugs (isoniazid).
• Acetylsalicylic acid should be used with caution during treatment with dexamethasone.
• Anticoagulants (coumarins and indandione derivatives).
• Some medicines may increase the effects of Dexamethasone Kern Pharma, so your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Do not stop taking any other steroid medicine unless your doctor has instructed you to do so.

Talk to your doctor, pharmacist, or nurse before taking this medicine.

Pregnancy and Breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

The use of Dexamethasone Kern Pharma during pregnancy is not recommended. However, your doctor will assess the risk/benefit ratio of its use.

Newborns of mothers who received Dexamethasone Kern Pharma near the end of pregnancy may have low blood sugar levels after birth.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Breastfeeding is not recommended for mothers treated with dexamethasone, as this medicine passes into breast milk.

Driving and use of machines

There is no known or available data on how Dexamethasone Kern Pharma affects the ability to drive or operate machinery. Therefore, avoid performing tasks that require special attention until you determine how you tolerate the medicine.

Important information about some of the components of Dexamethasone Kern Pharma

This medicine contains less than 23 mg of sodium per dose; hence, it is essentially “sodium-free.”

Influence on laboratory test results

This medicine may alter the values of certain laboratory tests:

• Blood: increased cholesterol and glucose levels, decreased calcium, potassium, and thyroid hormone levels.
• Urine: increased glucose.
• Skin tests: tuberculin and patch allergy tests.

If you are scheduled for any laboratory test, inform your doctor that you are using Dexamethasone Kern Pharma.

Use in athletes

This medicine contains a component that may produce a positive result in doping control tests.

3. How to use Dexametasona Kern Pharma

Follow exactly the instructions for administration of this medicine as given by your doctor. Your doctor will decide how long you should take dexamethasone. Consult your doctor or pharmacist if you have any doubts.

Dexametasona Kern Pharma 4 mg/ml is usually administered by a doctor or nurse.

Dexametasona Kern Pharma contains 4 mg of dexamethasone phosphate (equivalent to 3.33 mg of dexamethasone base) per vial for intravenous, intramuscular, intra-articular, intralesional, or soft tissue injection. It may be administered directly or may be added to a solution of physiological saline or glucose solution and given by infusion.

Dosage should be adjusted in patients with renal or hepatic impairment.

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED BASED ON THE DISEASE AND THE PATIENT'S RESPONSE

Intravenous and intramuscular route

As with other steroids, whenever the condition permits, the most appropriate dosing regimen for Dexametasona Kern Pharma is:

1. A single daily dose in the morning.

2. A single dose on alternate days.

The initial dose of Dexametasona Kern Pharma 4 mg/ml, expressed as dexamethasone phosphate, ranges between 0.5 and 9 mg per day, depending on the disease to be treated. In less severe conditions, lower doses of 0.5 mg may be sufficient, whereas in more severe diseases, doses exceeding 9 mg may be required. The initial dose should be maintained or adjusted until the patient's response is satisfactory. If, after a reasonable period of time, an adequate clinical response is not achieved, treatment should be discontinued and the patient's therapy changed.

Use in children:

In children, the recommended daily dose is 0.08–0.3 mg/kg or 2.5–10 mg/m², expressed as dexamethasone phosphate.

Intra-articular, intralesional, and soft tissue injection

This route of administration is used when joints or affected areas are limited to one or two sites. Dosage and frequency of administration vary depending on the condition and site of injection, with a usual dose of 0.2 to 6 mg, expressed as dexamethasone phosphate, and frequency ranging from once every 3–5 days to once every 2–3 weeks. Repeated administration of intra-articular injections may lead to damage of joint tissues.

If you feel that the effect of Dexametasona Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

For the treatment of Covid-19

In adult patients, it is recommended to administer 7.2 mg of dexamethasone phosphate (equivalent to 6 mg of dexamethasone base) intravenously once daily for up to a maximum of 10 days.

Use in adolescents

It is recommended to administer pediatric patients (adolescents at least 12 years of age) a dose of 7.2 mg of dexamethasone phosphate (equivalent to 6 mg of dexamethasone base) intravenously once daily for up to a maximum of 10 days.

If you use more Dexametasona Kern Pharma than you should

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

Acute intoxication or death due to overdose may occur in a very low percentage. Symptoms that may be observed include anxiety, depression, mental confusion, digestive spasms or hemorrhages, hyperglycemia, arterial hypertension, and edema. In such cases, administration of phenobarbital is indicated, in addition to symptomatic and supportive treatment, including oxygen therapy, maintenance of body temperature, adequate fluid intake, and monitoring of electrolytes in serum and urine. Gastrointestinal hemorrhage should be managed similarly to peptic ulcer disease.

If you stop treatment with Dexametasona Kern Pharma

Your doctor will inform you about the duration of your treatment with Dexametasona Kern Pharma. Do not stop treatment prematurely, as your condition may worsen again.

4. Possible adverse effects

Like all medicines, Dexamethasone Kern Pharma may produce adverse effects, although not everyone experiences them.

Below is a list of adverse effects. They have been classified using the following frequency definitions: very common (at least 1 in 10 patients), common (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients), and very rare (less than 1 in 10,000 patients).

The following adverse effects have been reported with dexamethasone:

Common:

• Immune system disorders: decreased resistance to infections, oropharyngeal candidiasis.
• Endocrine disorders: hyperglycaemia, adrenocortical insufficiency.
• With high doses: signs of adrenal hyperactivity (Cushing's syndrome) with rashes.
• Metabolism and nutrition disorders: polyphagia (increased appetite).
• Eye disorders: cataracts.
• Vascular disorders: with high doses: hot flushes.
• Gastrointestinal disorders: with high doses: gastric ulcer.
• Skin and subcutaneous tissue disorders: delayed wound healing, skin allergic reaction. With high doses: hirsutism (excessive hair growth), hyperpigmentation (skin darkening), scleroderma (disease of the subcutaneous tissue).
• Musculoskeletal and connective tissue disorders: osteoporosis, bone fragility. With prolonged treatment: muscle atrophy.

Uncommon:

• Blood and lymphatic system disorders: lymphopenia, eosinopenia.
• Immune system disorders: generalized allergic reaction.
• Endocrine disorders: amenorrhoea (absence of menstruation). With long-term administration, requiring medical attention: Cushing's syndrome, endocrine imbalance.
• Metabolism and nutrition disorders: hypokalaemia (decreased plasma potassium concentration), acute pancreatitis, pancreatitis.
• Nervous system disorders: increased intracranial pressure, neurological disturbances, psychotic states.
• Cardiac disorders: cardiac failure.
• Vascular disorders: thromboembolism, oedema, hypertension. With long-term administration, requiring medical attention: avascular necrosis, oedema.
• Skin and subcutaneous tissue disorders: sweating. With long-term administration, requiring medical attention: acne or other skin problems, injection site scarring.
• Musculoskeletal and connective tissue disorders: myasthenia (muscle weakness). With long-term administration, requiring medical attention: steroid myopathy (muscle weakness), striae, tendon rupture, osteoporosis or bone fractures.
• General disorders and administration site conditions: With rapid intravenous administration of high doses: allergic reactions and local injection site infection, generalized anaphylaxis, facial flushing, irregular heartbeat or palpitations, convulsions. With local injection: unusual bruising, wounds that do not heal.
• Gastrointestinal disorders: With long-term administration, requiring medical attention: gastrointestinal irritation, peptic ulcer or intestinal perforation.

Frequency unknown (cannot be estimated from available data):

• Eye disorders: visual disturbances, loss of vision, blurred vision.
• General disorder: hiccups.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually resolves after treatment is discontinued.

If any adverse reactions occur, treatment should be discontinued and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexamethasone Kern Pharma

Keep this medicine out of sight and reach of children.

Do not freeze. Store below 30°C. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine is for single use only and must be administered immediately after opening. Any unused portion should be discarded.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Only clear solutions free from cloudiness and precipitates should be used.

Other presentations: Clinical pack of 100 ampoules.

Composition

• The active substance is dexamethasone. Each ampoule contains: 4 mg of dexamethasone phosphate (as sodium dexamethasone phosphate, 4.37 mg), equivalent to 3.33 mg of dexamethasone base.
• The other components (excipients) are: disodium edetate, sodium citrate (E-331i), sodium hydroxide (E-524), and water for injections.

Nature of the product and contents of the container

Dexametasona Kern Pharma is a clear injectable solution supplied in packs containing 3 ampoules of 1 ml.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

This medicine should preferably be administered by direct intravenous injection or injected into an infusion line.

However, Dexametasona Kern Pharma 4 mg/ml solution for injection is compatible with the following infusion solutions (250 ml each) and must be used within 24 hours: 0.9% sodium chloride, Ringer's solution, or 5% glucose solution.