New marketing authorizations for metoclopramide drops will be granted again starting in August 2015. They will be available again in pharmacies at a concentration of 1 mg/ml, with a revised indication and duration of therapy. The 1 mg/ml metoclopramide solution is approved for adults for the treatment of nausea and vomiting (as an antiemetic) associated with chemotherapy, as well as for the prevention of these symptoms caused by radiation therapy or acute migraine.
Unlike before, the active ingredient concentration is now only a quarter. Therefore, dosing is no longer done with a dropper, but with a graduated pipette. It contains 5 ml, the recommended single dose for adults; two full pipettes are needed for 10 mg. The medication is intended to be reimbursable.
Five further marketing authorization applications for MCP in the concentration of 1 mg/ml and the dosage form "oral solution" are still pending at the Federal Institute for Drugs and Medical Devices (BfArM).
Background: Many migraine patients were able to effectively and well-toleratedly treat nausea and vomiting with metoclopramide (MCP), and also improve gastric motility. However, in April 2014, the marketing authorizations for all metoclopramide-containing oral drops with a concentration higher than 1 mg/ml were revoked. These products were withdrawn from the market. As a consequence of the revocation, all indications for chronic migraine symptoms were no longer valid. This came as a surprise to many migraine patients, and other options were often ineffective or poorly tolerated.
Antiemetics normalize gastrointestinal motility and relieve nausea and vomiting. Metoclopramide (MCP) is recommended at a standard adult dose of 20 drops. Rarely, fatigue, dizziness, or diarrhea occur as side effects. Very rarely, movement disorders such as involuntary mouth movements, throat and tongue spasms, head torsos, difficulty swallowing, or eye torsos may occur shortly after ingestion.
Metoclopramide (MCP) drops with an active ingredient concentration exceeding 1 mg/ml were no longer marketable and were recalled. All preparations available in Germany contained concentrations between 4 and 5 mg/ml and were therefore affected.
The reassessment is based on the known risk of severe cardiovascular and neurological side effects, particularly extrapyramidal symptoms and irreversible tardive dyskinesia. This risk increases with the dose used and the duration of treatment.
The newly approved metoclopramide drops, effective August 2015, now have a lower concentration of 1 mg/ml. The maximum dosage for adults is now 30 mg or 0.5 mg/kg body weight per day. For children, the dosage is based on body weight. A dose of 0.1 to 0.15 mg/kg body weight up to three times daily is recommended. The maximum 24-hour dose for children is also 0.5 mg/kg body weight. The duration of therapy has been limited to a maximum of five days. All indications for chronic symptoms have been removed as a result of the revocation of the previous marketing authorizations.
Loss of appetite, nausea, and vomiting can accompany migraine attacks. Additionally, the stomach muscles are often impaired in their motility. Antiemetics (from the Latin "emesis," meaning vomiting) are intended to correct these functional disturbances during migraines. Furthermore, the reduced stomach motility during a migraine also means that the usual migraine medications, taken as tablets, are only transported with difficulty into the intestines. The desired effect is then not achieved. For this reason, antiemetics are recommended as an adjunct to the treatment of migraine attacks. These medications are intended to normalize stomach motility and thus improve the effectiveness of the migraine medication.
Domperidone and dimenhydrinate remain available as alternatives for the treatment of nausea and vomiting during a migraine attack.
Domperidone has antiemetic and prokinetic effects. Domperidone has fewer extrapyramidal motor side effects than metoclopramide. When taken during the prodromal phase of migraine, domperidone reduced the likelihood of a subsequent headache phase in two studies. Domperidone is available as tablets and suspension. The assessment of the prokinetic agent domperidone (e.g., Motilium) has also been revised. Its indications have been restricted to the symptomatic treatment of nausea and vomiting. Adults weighing over 35 kg should only use domperidone orally at a maximum dose of 10 mg up to three times daily or rectally at a maximum dose of 30 mg twice daily. Children and adolescents weighing less than 35 kg should only receive domperidone orally at a maximum dose of 0.25 mg per kg of body weight up to three times daily. Domperidone should not be used for longer than one week due to cardiac side effects. Cardiac arrhythmias, such as life-threatening QT interval prolongations, have long been known as undesirable effects; therefore, domperidone should only be used with caution in patients with heart disease or electrolyte imbalances.
Dimenhydrinate has antiemetic but not prokinetic effects. Therefore, dimenhydrinate is only a second-line treatment for migraine attacks, unless the sedative side effect is desired. Dimenhydrinate is available as coated tablets, syrup, chewable tablets, suppositories, and for intravenous and injectable administration.
I suffer from positional vertigo, so I have to do so-called positioning maneuvers to get rid of it! With every exercise I vomited my heart out. The only thing that helped me was Paspertin, without which no exercise was possible
The remedy has always (!) helped me wonderfully. Never had any side effects. Unfortunately, since it is no longer as effective as it used to be, I just take 4 to 5 times the amount. Now it works again. It's all ok. Unfortunately it is more expensive. Has anyone ever thought about why the industry allows the approval of an important drug to expire? The end didn't come as a surprise
It's good that an indispensable medication is available again. Unfortunately, the new pack sizes only allow a three-day treatment for adults. In the case of a manifest gastrointestinal virus, this is not really practical.
MCP was and is always the first choice. Anyone who is not plagued by migraine attacks or has to deal with the consequences of chemotherapy cannot appreciate how important this medication is, regardless of whether it is in high or low doses! You simply have to take more to get the old effect that the patient is looking for.
I was so relieved when I heard that the drops had been taken off the market.
In 2012 I took 7 drops twice a day for several days because of stomach pain. What happened to me then was much, much worse than the stomach pain. I had extreme movement disorders. It was as if a force was pulling me down and I was lying on the floor. When I wanted to get into the car, I was “pulled” down next to the car door. For three weeks I only went to work by train. When I sat in the chair, I was “pulled” to the side, as if I were sitting on the plane during takeoff. My colleagues were shocked. I didn't feel dizzy, it wasn't like having low blood pressure. Every day I took these drops I had such “attacks”. It was so terrible. I would never take MCP drops again. I don't know what the current change is like, but I only took 7 drops and had these extreme side effects. Ingrid Brieden
Many doctors say MCP makes you psychotic. What nonsense!!!
If you take MCP and already have psychosis, that's understandable!
MCP is a very good medication!!!
What Sarina writes here is nonsense because logically you always have to assume that you will get side effects from an overdose and that has nothing to do with the concentration of the active ingredient!
Anyone who can read the package leaflet here has a clear advantage. In my opinion, taking these drops off the market was the worst decision that could have been made because it was the only medication that really did what it promised and for me without any side effects!
NOTE: I TOOK THE MEDICINE MYSELF UNTIL IT WAS RECALLED, almost 5 years.
I've been taking it again since it came back on the market.
In the meantime, however, I didn't have to go without, but instead stockpiled supplies in good time and ended up with tablets (10 mg) from a friend. He told me that the tablets were still available as usual, only the drops were affected. Before I could question this with my family doctor, the drops were approved again and the problem was solved (1mg/ml instead of 4mg/ml) MFG DASK
I once accidentally overdosed on the MCP drops and, based on this very frightening and unpleasant experience, I can only say that the active ingredient concentration should have been adjusted earlier.
Both the pharmaceutical companies and the regulatory authorities “play” quite lightly with the suffering of seriously ill patients. Because only they were extremely affected by the lockdown. Someone who occasionally took MCP for bloating certainly didn't miss the drug. For the others there were dramatic consequences!!!! How presumptuously everyone makes decisions, and those who are sometimes really tragically affected are left defenseless in the “battle”! There needs to be commissions for something like this in which those affected sit in order to weigh up whether, for example, such an important remedy should only be restricted to family doctor treatment.
Finally!!!!!!