Ragwitek

Ragwitek sublingual tablet (used under the tongue) is a prescription-only medicine that contains extract of allergy-causing short ragweed.

This product is used to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (red, itchy, and watery eyes). This method of treatment is called allergen immunotherapy.

Before using Ragwitek, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will do you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Not indicated for use in children due to limited data on safety and efficacy.

Geriatric: It may be used in elderly after assessing risks and benefits of the use. But not enough data is available on the safety and efficacy of this medicine in individuals above 65 years.

Pregnancy: It falls under pregnancy category C for all trimesters, meaning that due to lack of sufficient studies, it’s not clear if this medication is safe for use in pregnancy.

Breastfeeding: Use only after assessing risks and benefits of the use.

Drug interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

Inform you doctor about your intake of any other prescription or nonprescription medicine.

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.

Inform your doctor about the following conditions, if any:

• Allergy to ingredients of the preparation such as gelatin, mannitol, or sodium hydroxide
• Severe and uncontrolled asthma
• Serious systemic allergic reaction in the past: Do not use this medicine.
• History of eosinophilic esophagitis
• Treatment with other sublingual allergen immunotherapy in the past
• Unstable angina
• Abnormal heart rhythms (Arrhythmia)
• Breathing troubles or lung conditions such as COPD
• A recent heart attack
• Unchecked high blood pressure
• Oral conditions including tooth extraction, mouth ulcers, oral thrush, or oral surgery

To use Ragwitek properly, you must follow all instructions given by your doctor, and don’t take more, for longer or more frequently than recommended.

Read the medication guide carefully and follow accordingly. For any query, consult your doctor.

The treatment begins at least 12 weeks before the start of ragweed pollen season and continues with daily intake throughout the season.

You are kept under observation in a hospital or a clinic for at least half an hour after the administration of the first dose to look for any unusual reactions.

If no allergy is observed, you may be allowed to take the following doses at home.

How to use this medicine at home?

• Use this medicine only after properly washing and drying your hands.
• Remove the tablet from the blister pack only when you are ready to take it.
• Put the tablet under your tongue and allow it to dissolve.
• Do not swallow for about a minute.
• Wash your hands after each use.
• Avoid any food or drink for 5 minutes after taking the tablet.

Dosing: For best results, follow your doctor to know what amount of medicine you should take in a single dose. The doses of a medicine can differ according to the conditions for which it is being prescribed, your age and your overall health status.

Remember your doses can differ. Consult your doctor if you have anything to ask.

The doses of sublingual tablets are:

For short ragweed pollen rhinitis

• Adults up to 65 years: One tablet daily.
• Children: Not indicated in children.

Missed Dose: Take your missed dose once you remember but avoid it if it’s time to take your next dose, and follow your normal dosing schedule.

Avoid taking double doses to make up for the missed dose. Do not miss more than a dose. If you do, call your doctor before restarting it.

Storage:

• Store in a closed container at room temperature.
• Keep away from heat, moisture, and direct light.
• Do not freeze.
• Keep away from children.
• Discard any unused or expired medicines.

Before using Ragwitek, there are some precautions you must take. Your progress should be regularly monitored to determine if you are responding to the treatment or have undesirable side effects. Remember:

Seek emergency medical help if you have any signs of a life-threatening allergic reaction, anaphylaxis, including:

• Rapid and irregular breathing
• Shortness of breath or wheezing
• Fainting
• Unusual skin color in the face
• Rapid and irregular heart rhythm or pulse
• Hives
• Swollen eyelids or areas around

Talk to your doctor about using the emergency injection for anaphylaxis.

Call your doctor immediately if you have:

• Severe chest pain or swallowing difficulties, indicating an eosinophilic esophagitis.
• Breathing difficulties
• Uncontrollable asthma.

Consult your doctor before taking any prescription or nonprescription medicines and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Ragwitek.

Consult your doctor immediately if you have any of the following side effects:

More common: 

• Itchy ears and mouth
• Numb tongue
• Swollen mouth
• Tingling sensations around the mouth

Less common: 

• Chest discomfort
• Itchy skin
• Red, swollen, or painful tongue or inside of the mouth
• Swallowing problems

Incidence not known: 

• Cough
• Dizziness
• Hives or skin rash
• Puffed eyelids or areas around the eyes, face, lips, or tongue
• Rapid heartbeat
• Sweating
• Tightness in the chest

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common:

• Dry mouth
• Nausea

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.