Depo-medrol z Lidokainom

Package Leaflet: Information for the Patient

DEPO-MEDROL WITH LIDOCAINE,(40 mg + 10 mg)/ml, suspension for injection
(Methylprednisolone acetate + Lidocaine hydrochloride monohydrate)

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Depo-Medrol with lidocaine and what is it used for
• 2. Important information before using Depo-Medrol with lidocaine
• 3. How to use Depo-Medrol with lidocaine
• 4. Possible side effects
• 5. How to store Depo-Medrol with lidocaine
• 6. Contents of the pack and other information

1. What is Depo-Medrol with lidocaine and what is it used for

The active substance of Depo-Medrol with lidocaine, methylprednisolone acetate, belongs to a group of
glucocorticosteroids intended for internal use, and lidocaine hydrochloride monohydrate is a potent
local anesthetic.
Depo-Medrol with lidocaine should be used only for symptomatic treatment. The medicine is administered
periarthrically or intra-articularly.
Depo-Medrol with lidocaine is indicated for short-term local administration as supplementary therapy during
an acute episode or exacerbation of the following conditions:
synovitis in the course of degenerative joint disease
rheumatoid arthritis
post-traumatic degenerative joint disease
acute and subacute bursitis
epicondylitis
acute non-specific tenosynovitis
acute gouty arthritis
Depo-Medrol with lidocaine may also be used to treat ganglions, tendonitis, or tenosynovitis.

2. Important information before using Depo-Medrol with lidocaine

When not to use Depo-Medrol with lidocaine:

• if the patient is allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to lidocaine or other local anesthetics of the amide type
• in patients with generalized fungal infections
• for intrathecal (intracanal) administration
• for intravascular (e.g., intravenous) administration
• for intramuscular administration
• for epidural administration
• for administration into the nose and eye, as well as other areas (skin covering the skull, oral-pharyngeal cavity, palatine-uvular fold)
• in premature infants and newborns (see section 2)

Warnings and precautions

In patients with the following conditions, treatment with Depo-Medrol with lidocaine should be as short as possible and they require special medical care during treatment:

• Patients with diabetes: treatment with Depo-Medrol with lidocaine may cause the manifestation of latent diabetes or increase the need for insulin or oral antidiabetic drugs.
• Patients with hypertension: treatment with Depo-Medrol with lidocaine may exacerbate hypertension.
• Patients with a history of mental illness: treatment with Depo-Medrol with lidocaine may worsen existing emotional instability or psychotic tendencies.
• Patients with ocular herpes or herpetic keratitis: treatment with Depo-Medrol with lidocaine may increase the risk of corneal perforation.

Other warnings:

• Complications of glucocorticosteroid therapy depend on the dose and duration of treatment. The doctor will decide on the dosage and duration of treatment individually for each patient.
• You should tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
• Certain medicines may enhance the effect of Depo-Medrol with lidocaine, and the doctor may want to monitor the patient's condition closely when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
• Due to the possibility of skin and subcutaneous tissue atrophy, the doctor will recommend appropriate dosing and injection technique to minimize the occurrence of these complications.
• Corticosteroids, including methylprednisolone, may increase blood glucose levels, exacerbate existing diabetes, and predispose patients to diabetes.
• During treatment with Depo-Medrol with lidocaine and after its completion, psychiatric disorders may occur. They usually occur within a few days or weeks of starting treatment with Depo-Medrol with lidocaine. Most of them resolve after dose reduction or discontinuation of Depo-Medrol with lidocaine. Patients and their caregivers should consult a doctor if the patient develops psychotic symptoms, especially if they suspect depressive mood or suicidal thoughts. Patients and their caregivers should be aware of psychiatric disorders that may occur during treatment, immediately after dose reduction, or after discontinuation of Depo-Medrol with lidocaine.
• Depo-Medrol with lidocaine should be used with caution in patients with seizure disorders.
• Depo-Medrol with lidocaine should be used with caution in patients with myasthenia gravis.
• In patients taking corticosteroids, usually with long-term use of high doses, cases of lipomatosis have been reported.
• In patients taking Depo-Medrol with lidocaine long-term, posterior subcapsular cataract and nuclear cataract (especially in children) may develop, as well as exophthalmos or increased intraocular pressure, which can lead to glaucoma with potential optic nerve damage, and also contribute to the development of secondary eye infections caused by fungi or viruses.

...

Administration

In order to prevent infections during administration, it is necessary to use aseptic procedures.

• Intra-articular administration of corticosteroids may cause the patient to avoid overloading the joint in which the symptoms have been relieved. Failure to do so may exacerbate joint destruction, which would outweigh the benefits of steroid administration.
• Injections should not be made into unstable joints. In some cases, repeated intra-articular injections may cause joint instability. In selected cases, the doctor may decide to perform a control X-ray examination to detect any worsening of the joint condition.

...

Special precautions for the use of lidocaine for local anesthesia

The administration of local anesthetics, such as lidocaine, which is part of the methylprednisolone with lidocaine solution for injection, should be performed under conditions where immediate resuscitation can be initiated. Some local anesthesia procedures may be associated with serious adverse effects, regardless of the local anesthetic used, and are usually the result of elevated blood levels of the drug caused by accidental intravascular injection, overdose, or rapid absorption from highly vascularized areas of the body. They may also occur due to hypersensitivity, idiosynkrasy, or decreased patient tolerance. Systemic toxic effects mainly affect the central nervous system and/or cardiovascular system. Local anesthetics should be used with caution in patients with epilepsy, muscle weakness, conduction disorders, congestive heart failure, hypovolemia, and bradycardia. Children, adolescents, elderly patients, and patients with impaired immune systems require smaller doses, depending on age and physical condition.

Depo-Medrol with lidocaine and other medicines

You should tell your doctor about all medicines you are currently taking or plan to take, as well as medicines that you are taking without a prescription. Depo-Medrol with lidocaine may affect the action of other medicines, and other medicines may affect the action of Depo-Medrol with lidocaine.
It may be necessary to adjust the dose of Depo-Medrol with lidocaine when used concomitantly with the following medicines:
antibacterial medicines: isoniazid
antitubercular antibiotic: rifampicin

• anticoagulant medicines (oral). Concomitant use with Depo-Medrol with lidocaine may decrease or increase the effect of anticoagulant medicines. Blood coagulation indicators should be monitored to ensure adequate anticoagulant effect. antiepileptic medicines: carbamazepine, phenobarbital, phenytoin anticholinergic medicines: blocking neuromuscular conduction. When used concomitantly with high doses of Depo-Medrol with lidocaine and anticholinergic medicines, such as neuromuscular blocking agents, cases of acute myopathy have been reported. muscle relaxants, such as pancuronium, vecuronium; Depo-Medrol with lidocaine may partially inhibit neuromuscular blockade caused by muscle relaxants. anticholinesterases: Depo-Medrol with lidocaine may reduce the effect of anticholinesterases in patients with myasthenia gravis.
• antidiabetic medicines: in diabetic patients, it may be necessary to adjust the dose of antidiabetic medicines, as Depo-Medrol with lidocaine may increase blood glucose levels. antiemetic medicines: aprepitant, fosaprepitant antifungal medicines: itraconazole, ketoconazole antiviral medicines - HIV protease inhibitors: indinavir and ritonavir aromatase inhibitor: aminoglutethimide calcium channel blocker: diltiazem oral contraceptives: ethinyl estradiol/norethindrone grapefruit juice immunosuppressive medicines: cyclosporine. When used concomitantly with cyclosporine and Depo-Medrol with lidocaine, mutual inhibition of metabolism occurs, which may increase the concentration of one or both medicines in the blood. Therefore, there is a possibility that the risk of adverse effects associated with the use of one of the medicines may increase when used concomitantly. Seizures have been reported during concomitant use. immunosuppressive medicines: cyclophosphamide, tacrolimus macrolide antibacterial medicines: clarithromycin, erythromycin, troleandomycin
• nonsteroidal anti-inflammatory medicines (NSAIDs). Concomitant use of anti-inflammatory medicines with Depo-Medrol with lidocaine may increase the frequency of gastrointestinal bleeding and ulceration. Caution is advised when using aspirin (acetylsalicylic acid) in combination with Depo-Medrol with lidocaine. medicines that reduce potassium levels. When used concomitantly with Depo-Medrol with lidocaine and medicines that reduce potassium levels (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition where the potassium level in the blood is below the laboratory norm). Concomitant use of Depo-Medrol with lidocaine with amphotericin B, xanthines, or beta2 agonists increases the risk of hypokalemia.
• medicines that inhibit the metabolism of lidocaine (e.g., cimetidine). Concomitant use of medicines that inhibit the metabolism of lidocaine (e.g., cimetidine) and Depo-Medrol with lidocaine may cause an increase in lidocaine blood levels to potentially toxic concentrations in the case of multiple high-dose administration over a long period. However, these interactions are not clinically significant during short-term treatment with lidocaine at recommended doses. When using other local anesthetics or class IB antiarrhythmic medicines, lidocaine should be used with caution due to the potential for toxic effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fertility

Animal studies have shown that Depo-Medrol with lidocaine has a fertility-impairing effect.

Pregnancy

Methylprednisolone

Some animal studies have shown that corticosteroids administered to mothers can cause fetal developmental abnormalities.
However, it has not been shown that corticosteroids cause birth defects in fetuses whose mothers took corticosteroids during pregnancy.
Corticosteroids cross the placental barrier.
In one retrospective study, an increased incidence of low birth weight in newborns was found in mothers who took corticosteroids. In humans, the risk of low birth weight is dose-dependent. This risk can be reduced by using lower doses of corticosteroids.
Newborns born to mothers who took significant doses of Depo-Medrol with lidocaine during pregnancy should be closely monitored and examined for adrenal insufficiency, although adrenal insufficiency in newborns exposed to corticosteroids in utero appears to be rare.

Lidocaine

Lidocaine easily crosses the placental barrier.
Local administration of lidocaine during pregnancy and childbirth may cause adverse effects in the mother and fetus. Corticosteroids and lidocaine cross the placental barrier.

Methylprednisolone acetate with lidocaine

Until appropriate studies are conducted on the effect of Depo-Medrol with lidocaine on human reproductive processes, it should not be administered to pregnant women unless a thorough assessment of the benefit-to-risk ratio for the mother and fetus has been made.
The effect of corticosteroids on the course of labor is unknown.
In newborns born to mothers who took corticosteroids during pregnancy, cataract development has been observed.
Depo-Medrol with lidocaine contains benzyl alcohol and sodium

Breastfeeding

Methylprednisolone

Corticosteroids are excreted in breast milk.
In breastfed children, Depo-Medrol with lidocaine, which has been excreted in breast milk, may inhibit growth and affect the production of endogenous glucocorticosteroids.

Lidocaine

Lidocaine is excreted in breast milk.

Methylprednisolone acetate with lidocaine

This medicine may be used by breastfeeding women only after a thorough assessment of the benefit-to-risk ratio for the mother and infant.
Depo-Medrol with lidocaine contains benzyl alcohol and sodium

Driving and using machines

The effect of Depo-Medrol with lidocaine on the ability to drive and use machines has not been studied.
Patients who experience dizziness, balance disorders, vision disturbances, fatigue, temporary movement disorders, and impaired coordination while taking Depo-Medrol with lidocaine should not drive or operate machinery.
If anesthesia is performed in an outpatient setting, and the site of anesthesia affects the patient's ability to drive or operate machinery, patients should avoid these activities until full recovery.

Depo-Medrol with lidocaine contains benzyl alcohol and sodium

Depo-Medrol with lidocaine contains 8.7 mg of benzyl alcohol per 1 ml of solution, which corresponds to 8.7 mg/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Administration to small children is associated with the risk of serious adverse effects, including respiratory depression (so-called "gasping syndrome"). Do not use medicines containing benzyl alcohol in newborns (up to 4 weeks of age) or in small children (under 3 years of age) for more than one week without medical advice. Consult your doctor or pharmacist if you have liver or kidney disease, are pregnant, or are breastfeeding, as a large amount of benzyl alcohol may accumulate in the body and cause adverse effects, such as increased acid levels in the blood (metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means that the medicine is considered "sodium-free".

3. How to use Depo-Medrol with lidocaine

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Information on dosing and administration intended only for healthcare professionals is provided at the end of the leaflet.
Your doctor will decide on the appropriate dose, method, and site of administration of Depo-Medrol with lidocaine.
Treatment with Depo-Medrol with lidocaine does not eliminate the need for other medicines. Although this treatment method leads to symptom relief, it does not guarantee a cure, and the hormone does not affect the cause of the inflammation.

• 1. Rheumatoid arthritis and degenerative joint disease The dose for intra-articular administration depends on the size of the joint and the severity of the condition in the individual patient. The recommended doses may range from 4 mg to 80 mg. In cases of chronic conditions, injections can be repeated at intervals of one to five or more weeks, depending on the degree of symptom relief achieved with the first injection.
• 2. Bursitis The doctor will adjust the dose of the medicine administered into the bursa, depending on the severity of the disease and the patient's response to treatment.
• 3. Other conditions: ganglion, tendonitis, epicondylitis The doctor will adjust the dose of the medicine according to the severity of the condition and the patient's response to treatment. The recommended doses may range from 4 mg to 30 mg. In the treatment of recurrent or chronic conditions, repeated injections may be necessary. In many cases, a single injection of the medicine significantly reduces the size of the ganglion, and may even cause it to disappear. Each injection of Depo-Medrol with lidocaine should be performed under aseptic conditions.

Use in children and adolescents

Long-term treatment with Depo-Medrol with lidocaine should be used with caution in children and adolescents in divided daily doses. The doctor should limit the use of this type of treatment to the most severe indications (see section: warnings).

Use in patients with renal impairment

Depo-Medrol with lidocaine should be used with caution in patients with renal impairment.

Use of a higher than recommended dose of Depo-Medrol with lidocaine

Methylprednisolone
There is no clinical syndrome of acute methylprednisolone overdose.
Long-term use of the medicine in frequently repeated doses (once a day or several times a week) may cause Cushing's syndrome and other reactions related to chronic steroid treatment.
Lidocaine
Acute systemic toxicity symptoms
Central nervous system toxicity manifests with symptoms of increasing severity. Patients may initially experience: perioral paresthesia, tongue numbness, dizziness, hyperacusis, and tinnitus. Visual disturbances and muscle twitching or tremors are more severe symptoms and may precede the onset of generalized seizures. Do not confuse them with neurotic behaviors. The patient may lose consciousness and experience grand mal seizures, which can last from a few seconds to several minutes. Due to increased muscle activity during seizures, hypoxia and hypercapnia can quickly develop, as well as respiratory and airway obstruction. In severe cases, cardiac arrest may occur. Toxic effects of local anesthetics are enhanced by metabolic acidosis. In severe cases, cardiovascular symptoms may occur, including: hypotension, bradycardia, cardiac arrest, and arrhythmias, which can lead to death. Optimal oxygenation and ventilation of the patient, as well as cardiovascular support and treatment of metabolic acidosis, are crucial.

Overdose treatment

In case of symptoms of acute systemic toxicity, the injection of the anesthetic should be stopped immediately.

Missing a dose of Depo-Medrol with lidocaine

Do not take a double dose to make up for a missed dose.

Stopping treatment with Depo-Medrol with lidocaine

Only your doctor can decide to stop treatment. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, Depo-Medrol with lidocaine can cause side effects, although not everybody gets them.
The following side effects have been reported in association with Depo-Medrol with lidocaine, administered by the following routes:
intralesional or intrabursal: synovitis, gastrointestinal or urinary bladder disturbances, headache, meningitis, transverse paralysis (paraplegia), seizures, paresthesia.
Similar to other local anesthetics, lidocaine side effects are rare and usually associated with elevated blood levels caused by accidental intravascular injection, overdose, or rapid absorption from highly vascularized areas of the body. These effects may also occur due to hypersensitivity, idiosynkrasy, or decreased patient tolerance. Systemic toxic effects mainly affect the central nervous system and/or cardiovascular system. Neurological symptoms of systemic toxicity include: dizziness or a feeling of fainting, nervousness, tremors, perioral paresthesia, tongue numbness, drowsiness, seizures, coma. Cardiovascular reactions are depressant in nature and may manifest as: hypotension, bradycardia, cardiac arrest, arrhythmias, and in some cases, cardiac arrest or syncope. Symptoms of lidocaine toxicity may include: blurred vision, double vision, and transient blindness.

5. How to store Depo-Medrol with lidocaine

The medicinal product should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicinal product after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Package contents and other information

What Depo-Medrol with lidocaine contains

The active substances are: methylprednisolone acetate (40 mg) and lidocaine hydrochloride monohydrate (10 mg).
The other ingredients are: macrogol, benzyl alcohol (E1519), sodium chloride, myrystyl-gamma-picolinium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections (see section 2 "Depo-Medrol with lidocaine contains benzyl alcohol and sodium").

What Depo-Medrol with lidocaine looks like and what the package contains

The package contains 1 vial of colorless glass in a cardboard box.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium

To obtain more detailed information, please contact the local representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last update of the leaflet: 10/2024

Information intended exclusively for healthcare professionals

Treatment with Depo-Medrol with lidocaine does not eliminate the need for conventional measures. Although this treatment method leads to alleviation of symptoms, it does not provide complete recovery in any way, and the hormone does not affect the cause of inflammation.

• 1. Rheumatoid arthritis and degenerative joint disease The dose of methylprednisolone for intra-articular administration depends on the size of the joint and the severity of the condition being treated in the individual patient. In chronic cases, injections can be repeated at intervals of one to five or more weeks, depending on the degree of relief obtained from the first injection. The doses of methylprednisolone in the table below are given as a guide:

It is recommended that before performing an intra-articular injection, the anatomy of the given joint should be carefully reviewed. To achieve optimal anti-inflammatory effect, the injection should be made into the synovial space. Using aseptic technique, typical for performing a lumbar puncture, a sterile needle of size 20 to 24 (attached to a dry syringe) should be quickly inserted into the synovial space. To check if the needle has been inserted into the joint space, aspiration of only a few drops of synovial fluid should be performed. Injections into each joint are performed at the site where the synovial cavity is most superficial and is largely free from large vessels and nerves. After inserting the needle, the syringe is removed and replaced with another syringe containing the desired dose of Depo-Medrol with lidocaine. After injection, the needle is removed and a small dressing is applied.

• 2. Bursitis The area around the injection site should be carefully cleaned and, if necessary, local anesthesia should be applied.

A sterile needle of size 20 to 24 attached to a dry syringe is inserted into the bursa, and then the fluid is aspirated. The needle is left in place, and the syringe is replaced with another syringe containing the desired dose of the product. After injection, the needle is removed, and a small dressing is applied.

• 3. Other conditions: ganglion, tendonitis, epicondylitis In the treatment of such conditions as tendonitis or tenosynovitis, after applying an antiseptic agent, care should be taken to inject the suspension into the tendon sheath, not into the tendon tissue itself. The tendon is easier to feel by touch in the extended position. In the case of epicondylitis treatment, the borders of the area of greatest tenderness should be carefully determined, and the suspension should be injected into this area. In the case of ganglions of tendon sheaths, the suspension should be injected directly into the cyst. In many cases, a single injection of the drug significantly reduces the size of the ganglion cyst and can even cause it to disappear. Depending on the severity of the condition being treated, the administered doses may range from 4 to 30 mg. In the treatment of recurrent or chronic conditions, repeated injections may be necessary. Each injection should be performed under aseptic conditions (an antiseptic agent should be applied to the skin).

Administration instructions
Depo-Medrol with lidocaine should not be diluted or mixed with other solutions due to possible physical incompatibilities.
Medicines for parenteral administration should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Before use, shake vigorously to obtain a uniform suspension.
When using multidose vials, special care should be taken to prevent contamination of the vial contents.
The product is sterile; however, using multidose vials to withdraw multiple doses may lead to contamination unless strict aseptic technique is followed. Particular care should be taken when administering the product intra-articularly - in this case, single-dose syringes and needles should be used. There are data indicating that benzalkonium chloride is not a suitable antiseptic for sterilizing Depo-Medrol with lidocaine vials used for multiple doses. It is recommended to use a povidone-iodine solution or a similar product to clean the top of the vials before aspirating their contents.
It is not recommended to withdraw multiple doses of Depo-Medrol with lidocaine from one vial, in the case of intra-articular injection.