Adwiflam 75 mg Ampoules: A Complete Guide to Uses, Dosage, and Side Effects

We present a comprehensive and detailed analysis of the leaflet for Adwiflam 75 mg Ampoules, an effective pharmaceutical solution provided by Adwia. This medication contains the active ingredient diclofenac potassium, a compound belonging to the class of nonsteroidal anti-inflammatory drugs (NSAIDs), and is known for its potent properties in relieving pain, combating inflammation, and reducing fever. This guide aims to simplify the information in the official medical leaflet and present it clearly and understandably to the general public, focusing on indications, dosages, side effects, and important warnings to ensure safe and effective use.

What is Adwiflam 75 mg Ampoule and how does it work?

Adwiflam 75 mg Ampoule is a solution prepared for intramuscular injection, with each 3 ml containing 75 mg of diclofenac potassium. This medication is an ideal solution for conditions requiring rapid and potent pain relief, especially when oral administration is not possible or suitable.

The drug works by inhibiting prostaglandin enzymes, which are chemicals produced by the body that play a key role in causing pain, developing inflammation, and raising body temperature. By preventing the production of these substances, Adwiflam effectively controls these symptoms, making it a reliable treatment option in many acute medical conditions.

Therapeutic Indications

We recommend using Adwiflam Ampoule as a short-term treatment for the following acute conditions, under full medical supervision:

• Pain and inflammation after injuries: Very effective in relieving pain and swelling from injuries such as sprains and bruises.
• Pain and inflammation after surgery: Used to control pain and swelling after surgical procedures, especially in orthopedic and dental surgery.
• Renal colic and biliary colic: Provides rapid relief from the severe pain associated with kidney and gall bladder stones.

Dosage and Method of Administration

To ensure patient safety and achieve the best results, the dosage prescribed by the doctor must be followed.

• For adults only: The usual dose is one ampoule (75 mg) daily, administered by deep intramuscular injection.
• Duration of treatment: Treatment with injections should not exceed two consecutive days. If continued treatment is necessary, a switch should be made to other pharmaceutical forms such as tablets or suppositories.
• Children: The use of Adwiflam ampoules is not recommended for children.

Important Warnings and Contraindications

Adwiflam should be handled with extreme caution, as there are strict warnings and contraindications to prevent serious complications.

1. Cardiovascular Risks:

• NSAIDs may increase the risk of heart attacks, myocardial infarction, and fatal strokes.
• The drug is completely contraindicated for treating pain associated with coronary artery bypass graft (CABG) surgery.

2. Gastrointestinal Risks:

• These drugs can cause inflammation, bleeding, ulcers, or perforations in the stomach and intestines, which can be fatal.
• The elderly are more susceptible to these risks.

3. Other Contraindications:

• Hypersensitivity: It is contraindicated for patients with a known hypersensitivity to diclofenac or any other components of the drug, or those who have experienced allergic symptoms (asthma, urticaria) after taking aspirin.
• Peptic Ulcer: It is contraindicated in cases of active gastric or intestinal ulcers.
• Pregnancy and Lactation: Its use is not recommended during pregnancy and breastfeeding.
• Children and Infants: Not for use in children. The product contains benzyl alcohol, which can be fatal to newborns and infants.

Potential Side Effects

Like any other medication, Adwiflam Ampoule may cause some side effects that vary in severity from person to person.

• Gastrointestinal system: Stomach pain, nausea, vomiting, diarrhea, indigestion. Bleeding or ulcers rarely occur.
• Central nervous system: Headache, dizziness, vertigo. Drowsiness or memory disturbances rarely occur.
• Skin: Rash or itching. Severe skin reactions such as Stevens-Johnson syndrome rarely occur.
• Kidneys and Liver: May affect kidney and liver functions, especially with prolonged use, requiring periodic monitoring.
• Blood: Rarely causes anemia or thrombocytopenia.

Important Drug Interactions

The doctor should be informed of all medications you are taking, as Adwiflam can interact with other drugs, which may alter their effectiveness or increase the risk of side effects.

• Lithium and Digoxin: Adwiflam may increase their concentration in the blood.
• Diuretics: It may reduce the effect of diuretics and increase the risk of high potassium levels in the blood when used with potassium-sparing diuretics.
• Anticoagulants (blood thinners): Increases the risk of bleeding and requires close monitoring.
• Other nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use increases the frequency of side effects.
• Methotrexate and Cyclosporine: Increases the risk of their toxicity.

Frequently Asked Questions about Adwiflam 75 mg Ampoule

To clarify more important points, we have prepared a list of the most frequently asked questions.

When is it preferable to use Adwiflam injections instead of tablets?

Adwiflam injections are preferred in cases requiring a very rapid and potent therapeutic response for acute pain, as the effect of an intramuscular injection begins within minutes. They are also the optimal choice for patients who cannot take medication orally due to severe nausea, vomiting, or immediately after surgery. Injections are also used to treat severe pain attacks such as renal colic, where immediate pain relief is essential.

However, the use of injections should be limited to a short period not exceeding two consecutive days to minimize the risks of local and systemic side effects. Once the patient’s condition stabilizes and they are able to take medication orally, a switch should be made to other forms like tablets or capsules. This approach ensures a balance between the rapid efficacy needed initially and long-term safety, as determined by the treating physician based on a careful evaluation of the case.

Are Adwiflam injections safe for patients with high blood pressure and heart conditions?

Adwiflam injections must be used with extreme caution and under strict medical supervision for patients suffering from high blood pressure or heart disease. The active ingredient, diclofenac, belongs to the group of NSAIDs that can cause fluid and salt retention in the body. This effect can lead to an increase in blood pressure, an increased workload on the heart, and worsening of heart failure conditions. These drugs can also reduce the effectiveness of antihypertensive medications.

For patients with a history of heart attacks or strokes, using these injections may increase the risk of recurrence of these serious events. Therefore, the doctor carefully assesses the risks and benefits before prescribing the drug and may choose a safer alternative or recommend the lowest possible dose with continuous blood pressure monitoring. It is crucial not to use these injections without prior medical consultation if you have any heart or cardiovascular problems.

What precautions should be taken when receiving the injection?

To ensure that the Adwiflam injection is administered safely and effectively, several important precautions must be followed. First, the injection must be given by a medical professional (doctor or nurse) to ensure it is administered in the correct location, which is a deep intramuscular injection (usually in the buttock muscle). The injection site should be rotated each time to avoid local tissue irritation or damage. It is also necessary to ensure the skin at the injection site is clean and sterilized before administering the drug.

Second, it is important to monitor the patient after the injection to ensure no immediate allergic reactions occur, which may appear as a rash, difficulty breathing, or swelling. The ampoules contain benzyl alcohol as a preservative, which can cause allergic reactions in some individuals. The Adwiflam solution should not be mixed with other injection solutions in the same syringe to ensure no chemical reaction occurs.

Do Adwiflam injections cause pain at the injection site?

Yes, it is common for Adwiflam injections, like many other intramuscular injections, to cause some pain or discomfort at the injection site. The patient may feel a temporary sharp pain during needle insertion and injection of the drug, and this pain may persist for hours or even a day or two afterward. The pain may also be accompanied by mild swelling, redness, or hardening (induration) in the muscle. These are considered normal and expected local reactions.

To reduce this pain, it is advisable to administer the injection slowly and deeply into the muscle, which is done by an experienced healthcare provider. Cold compresses can also be applied to the injection site during the first few hours to reduce swelling and pain. If the pain is very severe, persists for more than a few days, or if signs of an abscess appear (such as severe swelling, local heat, and pus discharge), a doctor should be consulted immediately.

What is the difference between Adwiflam and Diclofen injections?

The main difference between Adwiflam injections and Diclofen (or Voltaren) injections often lies in the salt of the active ingredient used. Adwiflam injections contain diclofenac potassium, while many other products like Diclofen contain diclofenac sodium. Although both contain the same basic active ingredient (diclofenac) and have the same therapeutic effect, there are slight differences in their physical and chemical properties.

It is believed that the potassium salt dissolves and is absorbed slightly faster, which may lead to a relatively quicker onset of pain relief, making it preferable in some acute situations. However, when the drug is administered via intramuscular injection, this difference in absorption speed is less significant compared to oral administration. Ultimately, both types are highly effective, and the doctor’s choice between them depends on availability, cost, and personal preference based on clinical experience.

Can the injections be used to treat migraines?

Although diclofenac potassium is very effective in treating acute migraine attacks, the use of intramuscular injections is not the first or most common option for this purpose. Fast-acting oral dosage forms, such as immediate-release tablets or effervescent powders (like Adwiflam effervescent), are usually resorted to, as they provide a rapid onset of action suitable for most patients. The effervescent form is characterized by its very rapid absorption, providing quick relief from migraine pain.

However, in rare and very severe cases, especially when a migraine attack is accompanied by severe nausea and vomiting that prevent the patient from taking anything orally, a doctor in an emergency department might use Adwiflam injections. In such cases, the injection provides effective pain relief while bypassing the gastrointestinal problem. But for repeated and home use, oral forms remain the most suitable and safer option.

Why is the use of injections prohibited for more than two days?

It is strongly advised not to use Adwiflam injections for more than two consecutive days for several reasons related to safety and reducing the risk of side effects. First, repeated intramuscular injections in the same area can cause local damage to muscle tissue, nerve irritation, or even the formation of painful abscesses at the injection site. Therefore, limiting the duration of use aims to protect the integrity of the patient’s muscle tissue.

Second, the intensive use of high-dose NSAIDs is associated with an increased risk of serious systemic side effects, especially those related to the gastrointestinal tract (such as ulcers and bleeding), the cardiovascular system, and the kidneys. The injections are designed to provide a strong and rapid initial treatment, after which the patient’s condition should be reassessed and a switch made to a lower-concentration, safer oral treatment for long-term use if necessary, ensuring the continuity of treatment safely.

Do the injections affect kidney function?

Yes, Adwiflam injections and all NSAIDs can affect kidney function, especially with prolonged use, high doses, or in patients with certain risk factors. These drugs work by inhibiting prostaglandins, which are chemicals that not only cause pain and inflammation but also play a vital role in maintaining normal blood flow to the kidneys. When these substances are inhibited, blood flow to the kidneys may decrease, which can lead to impaired function.

This risk is particularly higher in the elderly, patients with heart failure, liver disease, or pre-existing kidney disease, as well as patients taking diuretics. Therefore, it is recommended to use these injections for the shortest possible duration and at the lowest effective dose, with periodic monitoring of kidney function if longer-term use is necessary. Patients with severe kidney problems should avoid this medication altogether.

What is the role of “benzyl alcohol” in the injections?

Benzyl Alcohol is added to the formulation of Adwiflam injections as an antimicrobial preservative. Its primary role is to prevent the growth of bacteria and fungi in the solution after the ampoule is opened, ensuring the medication remains sterile and safe for use and extending its shelf life. This is a very common practice in many medications that come in multi-dose vials or even in some single-dose containers to ensure sterility.

However, it is very important to note that benzyl alcohol can be toxic and dangerous when administered to newborns and infants, especially premature babies. Its use in this age group has been linked to a serious and fatal condition known as “Gasping Syndrome.” For this reason, the drug leaflet clearly states that this product is not intended for use in newborns and children, a warning that must be strictly adhered to in order to protect this vulnerable group.

Can pregnant or breastfeeding women use Adwiflam injections?

It is generally advisable to avoid using Adwiflam injections during pregnancy, and their use is completely contraindicated during the last three months of pregnancy (the third trimester). The use of NSAIDs at this advanced stage of pregnancy can lead to serious complications for the fetus, including premature closure of the ductus arteriosus in its heart, a negative impact on its kidney function, and it may also delay or prolong labor in the mother.

As for breastfeeding, very small amounts of diclofenac can pass through breast milk to the infant. Although these amounts are considered negligible and are unlikely to cause adverse effects on the baby, most manufacturers and doctors recommend avoiding the drug during lactation as a precautionary measure. A doctor should always be consulted to assess the urgent need for treatment and to weigh the potential benefits for the mother against the potential risks to the infant.