# Functional Dyspepsia

- Category: chronic
- Review status: reviewed (every claim checked against a document named on this page)
- Sources: Mirtazapine tablets US prescribing information, sections 2.1 and 3 (DailyMed SetID b6b31703-e77d-4d1a-b1ac-da972117e356, XLCare Pharmaceuticals): "Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily" and "Tablets: 7.5 mg, 15 mg functionally scored, 30 mg functionally scored and 45 mg." The 45 mg ceiling is the label's own maximum; the 7.5 mg start is one strength below the label's 15 mg starting dose, and the label carries no functional dyspepsia indication. · ACG/CAG Clinical Guideline: Management of Dyspepsia 2017 for the indication, with the dose from Amitriptyline Hydrochloride 25 mg Film-coated Tablets SmPC section 4.2 (eMC product 13683), which starts depression dosing at "Initially 25 mg 2 times daily (50 mg daily)" and states "Amitriptyline should not be used in children and adolescents aged less than 18 years". The SmPC's indication is depression; the 10 mg night-time start for functional dyspepsia is from the ACG/CAG guideline, which is not held in this corpus. · ACG/CAG Clinical Guideline: Management of Dyspepsia 2017 · Egyptian National Drug Formulary (EDA) 2026 - Gastrointestinal Tract · Functional Dyspepsia - disease-level clinical article (functional-dyspepsia-clinical.txt) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (domperidone monograph) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (metoclopramide monograph) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (famotidine monograph)
- Verified date: 2026-08

## Verified against

- Mirtazapine tablets US prescribing information, sections 2.1 and 3 (DailyMed SetID b6b31703-e77d-4d1a-b1ac-da972117e356, XLCare Pharmaceuticals): "Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily" and "Tablets: 7.5 mg, 15 mg functionally scored, 30 mg functionally scored and 45 mg." The 45 mg ceiling is the label's own maximum; the 7.5 mg start is one strength below the label's 15 mg starting dose, and the label carries no functional dyspepsia indication.
- ACG/CAG Clinical Guideline: Management of Dyspepsia 2017 for the indication, with the dose from Amitriptyline Hydrochloride 25 mg Film-coated Tablets SmPC section 4.2 (eMC product 13683), which starts depression dosing at "Initially 25 mg 2 times daily (50 mg daily)" and states "Amitriptyline should not be used in children and adolescents aged less than 18 years". The SmPC's indication is depression; the 10 mg night-time start for functional dyspepsia is from the ACG/CAG guideline, which is not held in this corpus.
- ACG/CAG Clinical Guideline: Management of Dyspepsia 2017
- Egyptian National Drug Formulary (EDA) 2026 - Gastrointestinal Tract
- Functional Dyspepsia - disease-level clinical article (functional-dyspepsia-clinical.txt)
- Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (domperidone monograph)
- Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (metoclopramide monograph)
- Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (famotidine monograph)

## Treatment metadata

- Omeprazole — 20 mg — oral.solid
- Referral & safety-netting (no drug therapy)
- Itopride — 50 mg — oral.solid
- Domperidone — 10 mg — oral.solid
- Metoclopramide — 10 mg — oral.solid
- Famotidine — 20 mg — oral.solid
- Amitriptyline — 10 mg — oral.solid
- Mirtazapine — oral.solid

## Complete treatment card

```text
FUNCTIONAL DYSPEPSIA
Sources: Mirtazapine tablets US prescribing information, sections 2.1 and 3 (DailyMed SetID
         b6b31703-e77d-4d1a-b1ac-da972117e356, XLCare Pharmaceuticals): "Starting dose: 15 mg once
         daily; may increase up to maximum recommended dose of 45 mg once daily" and "Tablets: 7.5
         mg, 15 mg functionally scored, 30 mg functionally scored and 45 mg." The 45 mg ceiling is
         the label's own maximum; the 7.5 mg start is one strength below the label's 15 mg starting
         dose, and the label carries no functional dyspepsia indication. · ACG/CAG Clinical
         Guideline: Management of Dyspepsia 2017 for the indication, with the dose from
         Amitriptyline Hydrochloride 25 mg Film-coated Tablets SmPC section 4.2 (eMC product 13683),
         which starts depression dosing at "Initially 25 mg 2 times daily (50 mg daily)" and states
         "Amitriptyline should not be used in children and adolescents aged less than 18 years". The
         SmPC's indication is depression; the 10 mg night-time start for functional dyspepsia is
         from the ACG/CAG guideline, which is not held in this corpus. · ACG/CAG Clinical Guideline:
         Management of Dyspepsia 2017 · Egyptian National Drug Formulary (EDA) 2026 -
         Gastrointestinal Tract · Functional Dyspepsia - disease-level clinical article (functional-
         dyspepsia-clinical.txt) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025
         (domperidone monograph) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025
         (metoclopramide monograph) · Egyptian National Drug Formulary - Gastrointestinal Tract 2025
         (famotidine monograph)
Review status: REVIEWED against 6 sources listed above  (2026-08)

IS IT THIS? - reference only, to read alongside your own examination
  SYMPTOMS - what the patient reports (6)
    - Diagnosis needs one of postprandial fullness, epigastric pain or burning, or early satiety,
      present for at least 3 months  [abdominal pain · early satiety · epigastric pain]
    - Epigastric burning or pain occurring at least once weekly and disrupting usual activity
      defines this subtype
    - Fullness after eating or early satiety that stops finishing a normal meal, happening at least
      3 days weekly, marks the other subtype  [early satiety]
    - Ongoing vomiting points away from simple dyspepsia toward a separate underlying condition
      [indigestion · vomiting]
    - Relief with passing gas or a bowel movement argues against calling it dyspepsia
    - Weight loss, dysphagia, odynophagia, unexplained anemia, or persistent vomiting are alarm
      features needing further evaluation  [anaemia · difficulty swallowing · painful swallowing ·
      vomiting · weight loss]
  SIGNS - what you find (1)
    - A palpable abdominal mass or lymphadenopathy on exam is an alarm feature prompting endoscopy
      [abdominal mass · lymphadenopathy]
  TESTS (2)
    - Initial workup includes a blood count, metabolic panel, thyroid tests, celiac serology,
      inflammatory markers, and H pylori testing
    - Endoscopy is routine at 60 or older regardless of red flags, and below 60 only when alarm
      features are present
  IF NOT THIS - what else fits (10)
    - Gastroesophageal reflux disease (GERD)
    - Helicobacter pylori infection
    - Gastritis
    - Peptic ulcer disease
    - Celiac disease
    - Irritable bowel syndrome (IBS)
    - Small intestinal bacterial overgrowth (SIBO)
    - Chronic pancreatitis
    - Gastroparesis
    - Gastric carcinoma (stomach cancer)
  Source  StatPearls "Functional Dyspepsia" - disease-level clinical article
  Status  traced to the source above

Rx: Main treatment  |  Prokinetic  |  Acid suppression - alternative to a PPI

MAIN TREATMENT - choose one
1. OMEPRAZOLE                                             [1st line]
   Adult    20 mg once daily 30 minutes before breakfast x 4-8 weeks
   Peds     Specialist pediatric gastroenterology use only
   Source   ACG/CAG Clinical Guideline: Management of Dyspepsia 2017
   Why      Proton pump inhibitor that blocks gastric acid secretion at the parietal cell
            H+/K+-ATPase, used as empirical first-line therapy for dyspepsia once H. pylori has been
            tested for and red-flag causes excluded.
   Caution  Test and treat for H. pylori prior to initiating uninvestigated long-term PPI therapy.
            In patients >55 years or with red flag symptoms (weight loss, dysphagia, anaemia,
            persistent vomiting), urgent endoscopy is mandatory before starting PPI.
            Attempt step-down or discontinuation after 4-8 weeks.
   Egypt    OMEGASTAZOLE 20MG 14 CAPS.       RIVA PHARMA S...    18.00 EGP (1.29/unit)
            OMEPRAL 20MG 14 CAPS.            MEMPHIS             32.00 EGP (2.29/unit)
            RISEK 20 MG 28 CAPS.             JULPHAR             75.00 EGP (2.68/unit)
            OMISEC 20MG 14CAPS.              THE UNITED PH...    42.00 EGP (3.00/unit)
            EPIRAZOLE 20MG 14CAPS.           EIPICO              44.00 EGP (3.14/unit)
            OMEPAK 20 MG 14 CAPS.            SEDICO              50.00 EGP (3.57/unit)
            RISEK 20 MG 14 CAPS.             JULPHAR             57.00 EGP (4.07/unit)
            NAPIZOLE 20MG 14 CAPS.           GLOBAL NAPI P...    62.00 EGP (4.43/unit)

2. REFERRAL & SAFETY-NETTING (NO DRUG THERAPY)            [1st line]
   Adult    
   Source   Functional Dyspepsia - disease-level clinical article (functional-dyspepsia-
            clinical.txt)
   Why      Carries the referral criteria and warning signs for this condition, which apply
            whichever treatment is chosen.
   Caution  RED FLAG - Alarm symptoms (unintentional weight loss, dysphagia, odynophagia,
            unexplained iron-deficiency anemia, persistent vomiting, a detectable
            mass/lymphadenopathy, family history of upper GI cancer) require endoscopic evaluation
            rather than empiric drug therapy.

3. AMITRIPTYLINE                                          [3rd line]
   Adult    10 mg once daily at bedtime, titrate to 25 mg at bedtime if needed x 8-12 weeks
   Peds     Not recommended for functional dyspepsia in children
   Choice   Amitriptyline is the first choice here; mirtazapine is a further option.
   Source   ACG/CAG Clinical Guideline: Management of Dyspepsia 2017 for the indication, with the
            dose from Amitriptyline Hydrochloride 25 mg Film-coated Tablets SmPC section 4.2 (eMC
            product 13683), which starts depression dosing at "Initially 25 mg 2 times daily (50 mg
            daily)" and states "Amitriptyline should not be used in children and adolescents aged
            less than 18 years". The SmPC's indication is depression; the 10 mg night-time start for
            functional dyspepsia is from the ACG/CAG guideline, which is not held in this corpus.
   Why      Low-dose tricyclic antidepressant acts as a visceral neuromodulator for refractory
            epigastric pain syndrome
   Caution  Used at low neuromodulatory doses (10-25 mg), not antidepressant doses.
            Anticholinergic side effects include dry mouth, sedation, and urinary retention.
            Avoid in cardiac arrhythmia or recent MI.
            Avoid in elderly patients, and in severe cardiovascular disease or arrhythmias.
            Amitriptyline - StatPearls - NCBI Bookshelf (NBK537225) puts amitriptyline on the
            American Geriatrics Society's Beers list, to be avoided in the elderly because its
            anticholinergic effect is so strong.
   Egypt    TRYPTIZOL 10 MG 20 TABS.         KAHIRA              10.00 EGP (0.50/unit)
            TRYPTIZOL 10 MG 60 TABS.         KAHIRA              30.00 EGP (0.50/unit)
            GRANITYLLIN 25MG/5ML SYP. 120 ML GRAND PHARMA ...     5.00 EGP
                -> ? strength differs, ? different route - not oral solid
            ZINOTRAVAL 25MG/5ML SYP. 120 ML  DEBEIKY > PHA...    10.00 EGP
                -> ? strength differs, ? different route - not oral solid

4. MIRTAZAPINE                                            [3rd line]
   Adult    Begin at 7.5 mg, taken 1 hour before going to bed. The sensible course is a low starting
            dose climbed slowly, to a ceiling of 45 mg daily.
   Peds     No paediatric dose is stated in the sources held for this drug.
   Source   Mirtazapine tablets US prescribing information, sections 2.1 and 3 (DailyMed SetID
            b6b31703-e77d-4d1a-b1ac-da972117e356, XLCare Pharmaceuticals): "Starting dose: 15 mg
            once daily; may increase up to maximum recommended dose of 45 mg once daily" and
            "Tablets: 7.5 mg, 15 mg functionally scored, 30 mg functionally scored and 45 mg." The
            45 mg ceiling is the label's own maximum; the 7.5 mg start is one strength below the
            label's 15 mg starting dose, and the label carries no functional dyspepsia indication.
   Why      Atypical antidepressant that improves early satiation, nutrient tolerance, and
            gastrointestinal-specific anxiety in functional dyspepsia.
   Caution  Higher doses may induce sedation without enhancing efficacy; cautiously titrate based on
            symptom response.
            Doses must be gradually tapered when discontinuing treatment.
            Begin low and climb slowly, to a ceiling of 45 mg daily.
   Egypt    RAMIZIPINE 30 MG 30 F.C. TABS.   AUG PHARMA          81.00 EGP (2.70/unit)
            RAPIZAPINE 30 MG 10 TAB.         EUROPEAN EGYP...    29.40 EGP (2.94/unit)
            MIRTADEPINE 30 MG 10 TAB.        ALFACURE PHAR...    37.00 EGP (3.70/unit)
            APRIMERTAZ 30 MG 30 F.C.TABS.    WADI ELNEEL B...   135.00 EGP (4.50/unit)
            MIRPRESION 30 MG 30 TABS.        BIOMED             151.50 EGP (5.05/unit)
            ZAPIMERT 30 MG 30 F.C. TABS.     DEBEIKY > GRO...   165.00 EGP (5.50/unit)
            REMERON 30 MG 10 TAB.            ORGANON > MUL...   135.00 EGP (13.50/unit)
            MIRTIMASH 30 MG 30 SCORED F.C. TABS. MASH PREMIERE                            177.00 EGP


PROKINETIC - choose one
5. ITOPRIDE                                               [2nd line]
   Adult    50 mg 3 times daily before meals x 4-8 weeks
   Peds     Not recommended in children
   Source   Egyptian National Drug Formulary (EDA) 2026 - Gastrointestinal Tract
   Why      Prokinetic agent with dopamine D2 and AChE inhibitory action; widely used in Egypt with
            lower cardiac/extrapyramidal risk than metoclopramide
   Caution  Useful for postprandial distress syndrome (fullness, early satiety).
            Avoid in GI haemorrhage, obstruction, or perforation.
            Discontinue if galactorrhea or gynecomastia occurs.
   Egypt    GANAMOTIL 50 MG 30 F.C.TABS.     INTERNATIONAL...    26.25 EGP (0.88/unit)
            EMA ITOPRIDE 50 MG 30 TABS.      PHAROPHARMA >...    48.00 EGP (1.60/unit)
            GANTOLIEF 50 MG 30 F.C.TABS.     GLOBAL NAPI P...    60.00 EGP (2.00/unit)
            GAROPRIDE 50 MG 30 F.C.TABS.     EVA PHARMA          63.00 EGP (2.10/unit)
            ITOMASH 50 MG 30 TABS.           MASH PREMIERE       63.00 EGP (2.10/unit)
            GANATON 50 MG 30 F.C.TABS.       KAHIRA > ABBO...    90.00 EGP (3.00/unit)
            ITOPRIDE 50 MG 30 SCORED TABS.   BORG                54.00 EGP
            ALKAPRIDE 50 MG 30 SCORED TABS.  FUTURE PHARMA...    90.00 EGP

6. DOMPERIDONE                                            [2nd line]
   Adult    10 mg up to three times daily (maximum 30 mg/day) - Maximum one week
   Peds     Age restriction: minimum 144 months
            (ENDF: children under 12 years and adolescents weighing less than 35 kg are not
            recommended.)
   Choice   Alternatives. The disease article names domperidone and metoclopramide as the
            prokinetics for functional dyspepsia and does not mention itopride, which was this
            card's only prokinetic. Domperidone is the printed default over metoclopramide because
            the ENDF caps metoclopramide at 5 days and contraindicates it in epilepsy and
            Parkinson's disease, which does not suit a chronic relapsing disorder.
   Source   Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (domperidone monograph)
   Why      The disease article names domperidone and metoclopramide as the prokinetics for
            functional dyspepsia; the card carried only itopride, which the article does not
            mention.
   Caution  Children under 12 years and adolescents weighing less than 35 kg are not recommended.
            Use at the lowest effective dose for the shortest duration necessary - maximum duration
            one week.
            Contraindicated with known existing prolongation of cardiac conduction intervals,
            particularly QTc, significant electrolyte disturbances, or underlying cardiac disease
            such as congestive heart failure.
            Contraindicated in moderate or severe hepatic impairment.
            Contraindicated where stimulating gastric motility is dangerous - gastrointestinal
            haemorrhage, mechanical obstruction, or perforation.
   Egypt    DOMPIDONE 10 MG 30 TAB.          ARAB DRUG COM...    17.25 EGP (0.57/unit)
            SYNCHROGIT 10MG 20 TAB.          RAMEDA              15.00 EGP (0.75/unit)
            MOTINORM 10MG 30 TABS.           GLAXO SMITHKLINE    28.25 EGP (0.94/unit)
            GASTROMOTIL 10MG 20 F.C. TAB.    EIPICO              26.00 EGP (1.30/unit)
            MOTILIUM 10MG 40 F.C.TAB.        MINA PHARM > ...   100.00 EGP (2.50/unit)
            GASTRONORM 10MG 5 SACHET         SIGMA                5.50 EGP
            MOTIL FAST 10 MG 10 EFF. SACHETS AMOUN               26.00 EGP
            DONARAX 10 MG 30 ORODISPERSIBLE TABS. JEDCO INT. CO. FOR PHARMACEUTICALS...    39.00 EGP
            DOMPIDONE 100MG/100ML ORAL SUSP. 100ML ARAB DRUG COMPANY (ADCO)                 6.00 EGP
                -> ? strength differs, ? different route - not oral solid
            MOTILIUM 1MG/ML SUSP. 100ML      MINA PHARM > ...    15.75 EGP
                -> ? strength differs, ? different route - not oral solid

7. METOCLOPRAMIDE                                         [2nd line]
   Adult    10 mg up to three times daily (maximum 30 mg/day or 0.5 mg/kg/day) - Maximum 5 days
   Peds     ENDF contraindicates metoclopramide in neonates and children under 1 year; the monograph
            gives no functional-dyspepsia paediatric dose, so none is stated here.
   Source   Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (metoclopramide
            monograph)
   Why      Named with domperidone as the guideline's prokinetic option for functional dyspepsia.
            The ENDF caps treatment at 5 days because of the extrapyramidal risk.
   Caution  Contraindicated in a history of neuroleptic or metoclopramide-induced tardive
            dyskinesia.
            Contraindicated in neonates or children aged under 1 year - increased risk of
            extrapyramidal disorders and methaemoglobinaemia.
            Contraindicated in epilepsy and in Parkinson's disease.
            Contraindicated in combination with levodopa or dopaminergic agonists.
            Contraindicated where stimulating gastrointestinal motility may be hazardous -
            mechanical obstruction, perforation, or haemorrhage.
            The maximum duration is 5 days.
   Egypt    CLOPRAM 10MG 20 TAB.             EL NASR              3.00 EGP (0.15/unit)
            PLEMAZOL 10MG 20 TAB.            CID                  3.20 EGP (0.16/unit)
            VOMAWAY 10MG 20 TAB.             MEMPHIS              8.50 EGP (0.42/unit)
            PRIMPERAN 10MG 10 SCORED TAB.    SANOFI              10.50 EGP


ACID SUPPRESSION - ALTERNATIVE TO A PPI
8. FAMOTIDINE                                             [2nd line]
   Adult    20 mg twice daily (mild, non-erosive); 40 mg twice daily (moderate, erosive)
   Peds     The ENDF famotidine monograph states paediatric doses for peptic ulcer and GERD, not for
            functional dyspepsia; no paediatric figure is carried here.
   Source   Egyptian National Drug Formulary - Gastrointestinal Tract 2025 (famotidine monograph)
   Why      An H2-receptor antagonist is the disease article's named alternative when a proton pump
            inhibitor is unsuitable; the card offered only omeprazole.
   Caution  The ENDF dose quoted here is the GERD regimen - the formulary has no functional-
            dyspepsia entry for famotidine, and the indication comes from the disease article.
   Egypt    FAMOTAK 20MG 20 F.C.TAB.         SEDICO              28.00 EGP (1.40/unit)
            GASTRODOMINA 20MG 20 TAB.        MUP > ALMIRAL...    28.00 EGP (1.40/unit)
            ANTODINE 20 MG 30 F.C.TABS.      AMOUN               60.00 EGP (2.00/unit)
            FAMOTIN 20MG 20TAB.              MEMPHIS             40.00 EGP (2.00/unit)
            RANI-F 20MG 6 SACHETS            PHARCO              42.00 EGP

Prices are indicative (dataset snapshot 2026-06); verify with the pharmacy.
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